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Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009814
Recruitment Status : Completed
First Posted : November 9, 2009
Results First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: BMS-663068
Drug: Ritonavir
Enrollment 50
Recruitment Details This was a randomized, open label, multiple-dose study to evaluate the pharmacodynamics, safety and pharmacokinetics of BMS-663068 in human immunodeficiency virus 1 (HIV-1) infected participants. The study was conducted at single center in Germany.
Pre-assignment Details A total of 75 participants were screened, of which 25 were screen failure, and 50 eligible participants were enrolled into the study and were randomized.
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8. All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8. All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8. All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8. All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Period Title: Overall Study
Started 10 10 10 10 10
Completed 9 9 10 10 10
Not Completed 1 1 0 0 0
Reason Not Completed
No longer met study criteria             1             1             0             0             0
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H Total
Hide Arm/Group Description All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8. All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8. All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8. All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8. All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8. Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 10 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
41.3  (8.29) 40.7  (13.70) 40.7  (6.53) 38.4  (7.83) 42.7  (8.42) 40.8  (9.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
Female
1
  10.0%
1
  10.0%
1
  10.0%
0
   0.0%
0
   0.0%
3
   6.0%
Male
9
  90.0%
9
  90.0%
9
  90.0%
10
 100.0%
10
 100.0%
47
  94.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
White
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
50
 100.0%
1.Primary Outcome
Title Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9
Hide Description The primary assessment of the antiviral activity of BMS-663068 was assessed on the log10 change from Baseline in HIV RNA to Day 9. Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline value from post-Baseline visit value. An analysis of covariance (ANCOVA) model correcting for Baseline HIV viral load and treatment group was used to test the differences in mean log10 decrease in HIV RNA at Day 9 between 2 regimen groups by antiretroviral treatment history (ARV [antiretroviral] naive, ARV experienced, and combined [ARV naive + ARV experienced]). For the combined group (ARV naive +ARV experienced) an additional ANCOVA was used correcting also for treatment history as an additional covariate. Only Clade B participants were included in the population.
Time Frame Baseline and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. It comprised of all participants for whom pharmacodynamic measurements were available at Baseline and at least one other time.
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 9 9 10 10 10
Mean (Standard Error)
Unit of Measure: Log10 copies per milliliter (c/mL)
-1.3445  (0.07925) -1.2532  (0.10610) -1.2381  (0.10455) -1.1888  (0.12938) -0.8760  (0.22621)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BMS-663068 600 mg Q12H + RTV 100 mg Q12H, BMS-663068 1200 mg QHS + RTV 100 mg QHS
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6102
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1089
Confidence Interval (2-Sided) 90%
-0.4656 to 0.2477
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2120
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BMS-663068 600 mg Q12H + RTV 100 mg Q12H, BMS-663068 1200 mg Q12H + RTV 100 mg Q12H
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5452
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1266
Confidence Interval (2-Sided) 90%
-0.4758 to 0.2225
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2076
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BMS-663068 600 mg Q12H + RTV 100 mg Q12H, BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4178
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1682
Confidence Interval (2-Sided) 90%
-0.5139 to 0.1775
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2055
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BMS-663068 600 mg Q12H + RTV 100 mg Q12H, BMS-663068 1200 mg Q12H
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0233
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4885
Confidence Interval (2-Sided) 90%
-0.8375 to -0.1395
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2075
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BMS-663068 1200 mg QHS + RTV 100 mg QHS, BMS-663068 1200 mg Q12H + RTV 100 mg Q12H
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9314
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0177
Confidence Interval (2-Sided) 90%
-0.3613 to 0.3259
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2043
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BMS-663068 1200 mg QHS + RTV 100 mg QHS, BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7734
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0592
Confidence Interval (2-Sided) 90%
-0.4032 to 0.2847
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2045
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BMS-663068 1200 mg QHS + RTV 100 mg QHS, BMS-663068 1200 mg Q12H
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0702
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3796
Confidence Interval (2-Sided) 90%
-0.7232 to -0.0360
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2043
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BMS-663068 1200 mg Q12H + RTV 100 mg Q12H, BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8359
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0415
Confidence Interval (2-Sided) 90%
-0.3768 to 0.2937
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1993
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BMS-663068 1200 mg Q12H + RTV 100 mg Q12H, BMS-663068 1200 mg Q12H
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0759
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3619
Confidence Interval (2-Sided) 90%
-0.6962 to -0.0275
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1988
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BMS-663068 1200 mg Q12H + RTV 100 mg QAM, BMS-663068 1200 mg Q12H
Comments Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1155
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3203
Confidence Interval (2-Sided) 90%
-0.6555 to 0.0149
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1993
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count
Hide Description Blood samples were collected for evaluation of CD4+ and CD8+ cells at Baseline (Day 1, pre-dose), Day 8, Day 15 (Follow up) and Day 50 (study discharge). Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline value from post-Baseline visit value.
Time Frame Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 9 9 10 10 10
Mean (Standard Error)
Unit of Measure: Cells per microliter (cells/μL)
CD4+, Day 8, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
114.2  (74.55) 93.4  (25.12) 109.8  (32.37) 38.5  (41.61) 32.0  (36.23)
CD4+, Day 15, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
58.4  (92.14) -6.1  (28.15) 117.6  (27.67) 44.6  (69.94) 10.4  (23.38)
CD4+, Day 50, n=9, 9, 10, 10, 9 Number Analyzed 9 participants 9 participants 10 participants 10 participants 9 participants
22.0  (91.55) -50.3  (18.06) 71.1  (28.55) -48.4  (61.21) -19.2  (17.05)
CD8+, Day 8, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
384.2  (164.35) 189.0  (134.27) 218.4  (125.65) 114.9  (131.64) 94.6  (152.73)
CD8+, Day 15, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
64.8  (230.86) -153.2  (137.18) 85.6  (112.65) -99.6  (159.83) -4.4  (126.77)
CD8+, Day 50, n=9, 9, 10, 10, 9 Number Analyzed 9 participants 9 participants 10 participants 10 participants 9 participants
-37.6  (161.11) -292.4  (121.73) 139.7  (95.00) 6.0  (170.29) -48.2  (140.55)
3.Secondary Outcome
Title Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count
Hide Description Blood samples were collected for evaluation of percent CD4+ and percent CD8+ cells at Baseline (Day 1, pre-dose), Day 8, Day 15 (Follow up) and Day 50 (study discharge). Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline visit value from post-Baseline visit value.
Time Frame Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 9 9 10 10 10
Mean (Standard Error)
Unit of Measure: Percent cells per microliter
Percent CD4+, Day 8, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
-1.0  (1.12) 1.2  (0.97) 0.6  (0.78) 0.1  (0.72) 1.4  (1.11)
Percent CD4+, Day 15, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
1.6  (1.00) 1.2  (0.64) 1.4  (1.33) 2.4  (1.11) 0.9  (1.51)
Percent CD4+, Day 50, n=9, 9, 10, 10, 9 Number Analyzed 9 participants 9 participants 10 participants 10 participants 9 participants
1.4  (0.84) 1.1  (1.15) 0.3  (0.90) -1.7  (0.97) 0.6  (1.45)
Percent CD8+, Day 8, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
1.0  (0.76) -0.4  (1.02) 0.1  (1.06) -0.3  (1.11) -0.2  (1.20)
Percent CD8+, Day 15, n=9, 9, 10, 10, 10 Number Analyzed 9 participants 9 participants 10 participants 10 participants 10 participants
-3.4  (0.73) -2.8  (1.00) -2.9  (1.49) -4.0  (1.73) -2.9  (1.16)
Percent CD8+, Day 50, n=9, 9, 10, 10, 9 Number Analyzed 9 participants 9 participants 10 participants 10 participants 9 participants
-2.2  (1.01) -0.7  (1.22) -0.9  (1.19) 1.6  (1.52) -2.4  (1.57)
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE)
Hide Description An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Treatment emergent adverse events (occurred after start of treatment) have been presented.Safety Population comprised of all randomized participants who used the trial medication at least once.
Time Frame Up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Non-SAE
8
  80.0%
5
  50.0%
9
  90.0%
8
  80.0%
9
  90.0%
SAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Any Abnormality in Physical Examination
Hide Description A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. A brief physical examination included, at a minimum assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Any abnormality found by investigator during physical examination were recorded. Number of participants with any abnormality in physical examination during study have been reported.
Time Frame Up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
  10.0%
0
   0.0%
2
  20.0%
1
  10.0%
1
  10.0%
6.Secondary Outcome
Title Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description Vital signs including DBP and SBP were recorded. Normal ranges were as following: For DBP, lower limit: value <55 millimeter of mercury (mmHg) and change <-20 mmHg; upper limit: value >90 mmHg and change >20 mmHg). For SBP, lower limit: value <90 mmHg and change <-10 mmHg; upper limit: value >140 mmHg and change >10 mmHg. Number of participants with worst-case abnormalities are presented. Worst-case abnormality was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. (3) Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.
Time Frame Up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
SBP, Above Normal
0
   0.0%
3
  30.0%
1
  10.0%
0
   0.0%
1
  10.0%
SBP, Below Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
SBP, Within Normal
10
 100.0%
7
  70.0%
9
  90.0%
10
 100.0%
9
  90.0%
DBP, Above Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
DBP, Below Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
DBP, Within Normal
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
7.Secondary Outcome
Title Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR]
Hide Description Vital signs (body temperature, RR, and HR) were recorded. Normal range were: For HR, lower limit: 55 beats per minute (bpm) and change <-15 bpm; upper limit: >100 bpm and change >30 bpm). For temperature, lower limit: 36.0 Celsius; upper limit: >37.5 Celsius or change >1.7 Celsius). For RR, lower limit: 8 breaths per minute; upper limit: >16 breaths per minute or change >10 breaths per minute. Number of participants with worst-case abnormalities are presented. Worst-case abnormality was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. (3) Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.
Time Frame Up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
HR, Above Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HR, Below Normal
1
  10.0%
2
  20.0%
1
  10.0%
0
   0.0%
1
  10.0%
HR, Within Normal
9
  90.0%
8
  80.0%
9
  90.0%
10
 100.0%
9
  90.0%
RR, Above Normal
4
  40.0%
3
  30.0%
3
  30.0%
3
  30.0%
8
  80.0%
RR, Below Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
RR, Within Normal
6
  60.0%
7
  70.0%
7
  70.0%
7
  70.0%
2
  20.0%
Temperature, Above Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Temperature, Below Normal
1
  10.0%
2
  20.0%
0
   0.0%
1
  10.0%
0
   0.0%
Temperature, Within Normal
9
  90.0%
8
  80.0%
10
 100.0%
9
  90.0%
10
 100.0%
8.Secondary Outcome
Title Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters
Hide Description A 12-lead ECG was recorded during the study using an ECG machine that automatically measures ECG parameters. Normal range for ECG parameters were: PR interval (upper: 200 milliseconds [ms]); QRS (lower: 50 ms; upper: 120 ms); Corrected QT interval by Bazett formula (QTcB) (change from Baseline - increases by > 30 ms); Corrected QT interval by Fredericia formula (QTcF) (change from Baseline - increases by > 30 ms). Number of participants with worst-case abnormalities are presented which was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.
Time Frame Up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
PR interval, Above Normal
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
  10.0%
PR interval, Below Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PR interval, Within Normal
10
 100.0%
9
  90.0%
10
 100.0%
10
 100.0%
9
  90.0%
QTcB, Above Normal
0
   0.0%
1
  10.0%
2
  20.0%
0
   0.0%
1
  10.0%
QTcB, Below Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTcB, Within Normal
10
 100.0%
9
  90.0%
8
  80.0%
10
 100.0%
9
  90.0%
QTcF, Above Normal
1
  10.0%
0
   0.0%
1
  10.0%
0
   0.0%
2
  20.0%
QTcF, Below Normal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTcF, Within Normal
9
  90.0%
10
 100.0%
9
  90.0%
10
 100.0%
8
  80.0%
9.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Hide Description Laboratory parameters included hematology, clinical chemistry and urine parameters. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Any abnormal laboratory test results which were considered clinically significant by the investigator were recorded on the case report form. Number of participants with any clinically significant abnormalities in laboratory parameters have been presented.
Time Frame Up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess Cmax of BMS-626529 following Q12H dosing. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (Anti Meridiem [AM]), Day 8 evening dose (Post Meridiem [PM]) and Day 8 morning + evening dose (AM+PM). Pharmacokinetic parameter values were derived by non-compartmental methods. Pharmacokinetic (PK) Population was used which comprised of all participants who receive BMS-663068 and provided pharmacokinetic samples.
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter (μg/mL)
Day 1, n=10,10,10,10 Number Analyzed 10 participants 10 participants 10 participants 10 participants
1.74
(59.9%)
3.52
(26.6%)
4.05
(35.8%)
2.55
(27.4%)
Day 8, AM, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
2.22
(67.1%)
5.55
(37.5%)
5.10
(57.4%)
3.18
(22.0%)
Day 8, PM, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
2.25
(46.4%)
4.60
(29.2%)
4.77
(36.2%)
3.61
(27.5%)
Day 8, AM+PM, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
2.24
(43.3%)
5.05
(31.7%)
4.93
(40.1%)
3.39
(15.9%)
11.Secondary Outcome
Title Cmax of BMS-626529 Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess Cmax of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 evening dose (PM) and Day 8 morning (AM) + evening dose (PM).
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Day 1, n=10 Number Analyzed 10 participants
3.85
(32.0%)
Day 8, PM, n=9 Number Analyzed 9 participants
3.47
(31.7%)
Day 8, AM+PM, n=9 Number Analyzed 9 participants
3.47
(31.7%)
12.Secondary Outcome
Title Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to access Ctrough of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8, Day 8 morning dose (AM) and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Days 5,6,7: pre-morning dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter (μg/mL)
Day 1, n=10,10,10,10 Number Analyzed 10 participants 10 participants 10 participants 10 participants
0.349
(156%)
0.499
(83.4%)
0.640
(114%)
0.244
(78.3%)
Day 5, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
0.473
(119%)
1.04
(72.2%)
0.760
(67.1%)
0.518
(48.2%)
Day 6, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
0.436
(89.5%)
0.839
(49.1%)
0.737
(73.2%)
0.451
(49.2%)
Day 7, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
0.495
(96.5%)
1.08
(72.9%)
0.998
(91.8%)
0.542
(73.5%)
Day 8, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
0.460
(89.2%)
0.743
(47.1%)
0.720
(83.5%)
0.628
(76.9%)
Day 8, AM, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
0.422
(69.1%)
0.951
(88.2%)
0.579
(71.5%)
0.469
(122%)
Day 8, PM, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
0.358
(102%)
0.653
(109%)
0.553
(68.1%)
0.487
(47.5%)
13.Secondary Outcome
Title Ctrough of BMS-626529 Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess Ctrough of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8 and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Day 1, n=10 Number Analyzed 10 participants
0.699
(93.4%)
Day 5, n=9 Number Analyzed 9 participants
0.0705
(114%)
Day 6, n=9 Number Analyzed 9 participants
0.0743
(97.7%)
Day 7, n=9 Number Analyzed 9 participants
0.0719
(166%)
Day 8, n=9 Number Analyzed 9 participants
0.0546
(146%)
Day 8, PM, n=9 Number Analyzed 9 participants
0.0544
(156%)
14.Secondary Outcome
Title Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-626529 Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (tau) of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM) and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
Day 1, n=10,10,10,10 Number Analyzed 10 participants 10 participants 10 participants 10 participants
9.16
(68.7%)
18.3
(28.8%)
20.6
(45.0%)
13.8
(28.3%)
Day 8, AM, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
13.1
(62.7%)
29.9
(37.0%)
27.6
(48.4%)
19.5
(20.5%)
Day 8, PM, n=9,10,10,10 Number Analyzed 9 participants 10 participants 10 participants 10 participants
13.1
(63.8%)
30.6
(26.3%)
27.0
(45.2%)
22.5
(34.0%)
15.Secondary Outcome
Title AUC (Tau) of BMS-626529 Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (tau) of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1 and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
Day 1, n=10 Number Analyzed 10 participants
25.5
(38.0%)
Day 8 PM, n=9 Number Analyzed 9 participants
23.0
(48.2%)
16.Secondary Outcome
Title Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (0-24) of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.
Time Frame Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
26.8
(56.1%)
60.6
(30.6%)
55.1
(44.3%)
42.6
(21.5%)
17.Secondary Outcome
Title AUC (0-24) of BMS-626529 Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (0-24) of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.
Time Frame Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
23.0
(48.2%)
18.Secondary Outcome
Title Accumulation Index (AI) of BMS-626529 Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess Accumulation Index of BMS-626529 following Q12H dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 morning dose (AM).
Time Frame Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 9 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of AUC
1.53
(49.4%)
1.63
(26.7%)
1.34
(25.4%)
1.42
(37.0%)
19.Secondary Outcome
Title Accumulation Index of BMS-626529 Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess Accumulation Index of BMS-626529 following QHS dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 evening dose (PM).
Time Frame Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of AUC
0.912
(27.1%)
20.Secondary Outcome
Title Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measures were used in evaluating IQ: Cmin and Css,avg. Geometric mean and geometric coefficient of variation are presented.
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Day 9: pre-dose, 4,12 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-morning dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 8 9 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
IQ Cmin
11.0
(3510%)
97.5
(382%)
67.2
(543%)
4.54
(21600%)
IQ Css,avg
29.7
(4040%)
327
(454%)
252
(789%)
15.4
(14900%)
21.Secondary Outcome
Title Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measures were used in evaluating IQ: Cmin and Css,avg. Geometric mean and geometric coefficient of variation are presented.
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Day 2: pre-evening dose, 12,16 hours; Day 9: pre-dose, 12,16 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-evening dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
IQ Cmin
3.86
(1070%)
IQ Css,avg
67.8
(902%)
22.Secondary Outcome
Title Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measure was used in evaluating IQ: Ctrough. Geometric mean and geometric coefficient of variation are presented.
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Day 9: pre-dose, 4,12 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-morning dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Number of Participants Analyzed 8 9 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
12.2
(2750%)
120
(568%)
87.3
(763%)
4.61
(19000%)
23.Secondary Outcome
Title Inhibitory Quotient of BMS-626529 by Ctrough Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measure was used in evaluating IQ: Ctrough. Geometric mean and geometric coefficient of variation are presented.
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 2: pre-evening dose, 12,16 hours; Day 9: pre-dose, 12,16 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-evening dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
4.77
(1010%)
24.Secondary Outcome
Title Cmax of Ritonavir Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess Cmax of ritonavir following Q12H dosing. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM), Day 8 evening dose (PM) and Day 8 morning + evening dose (AM+PM). Pharmacokinetic parameter values were derived by non-compartmental methods. PK Population was used which comprised of all participants who receive ritonavir and provided pharmacokinetic samples.
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter (μg/mL)
Day 1, n=10,10,10 Number Analyzed 10 participants 10 participants 10 participants
0.330
(91.3%)
0.314
(111%)
0.294
(59.6%)
Day 8, AM, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
1.31
(101%)
1.30
(58.3%)
0.841
(44.9%)
Day 8, PM, n=9,10,0 Number Analyzed 9 participants 10 participants 0 participants
1.24
(73.4%)
1.48
(47.7%)
Day 8, AM+PM, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
1.27
(80.0%)
1.39
(50.7%)
0.841
(44.9%)
25.Secondary Outcome
Title Cmax of Ritonavir Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess Cmax of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 evening dose (PM) and Day 8 morning (AM) + evening dose (PM).
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Day 1, n=10 Number Analyzed 10 participants
0.257
(53.8%)
Day 8, PM, n=9 Number Analyzed 9 participants
0.628
(56.4%)
Day 8, AM+PM, n=9 Number Analyzed 9 participants
0.628
(56.4%)
26.Secondary Outcome
Title Ctrough of Ritonavir Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to access Ctrough of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8, Day 8 morning dose (AM) and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Days 5,6,7: pre-morning dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter (μg/mL)
Day 1, n=10,10,0 Number Analyzed 10 participants 10 participants 0 participants
0.117
(90.1%)
0.131
(98.2%)
Day 5, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
0.502
(84.3%)
0.554
(73.9%)
0.0831
(77.8%)
Day 6, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
0.526
(87.9%)
0.594
(77.0%)
0.0820
(77.9%)
Day 7, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
0.477
(93.5%)
0.587
(76.3%)
0.0860
(79.9%)
Day 8, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
0.470
(90.6%)
0.503
(73.2%)
0.0891
(81.7%)
Day 8, AM, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
0.345
(105%)
0.393
(66.3%)
0.0912
(70.5%)
Day 8, PM, n=9,10,0 Number Analyzed 9 participants 10 participants 0 participants
0.453
(86.2%)
0.476
(77.9%)
27.Secondary Outcome
Title Ctrough of Ritonavir Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess Ctrough of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8 and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Day 1, n=10 Number Analyzed 10 participants
0.157
(87.0%)
Day 5, n=9 Number Analyzed 9 participants
0.107
(69.4%)
Day 6, n=9 Number Analyzed 9 participants
0.0845
(67.7%)
Day 7, n=9 Number Analyzed 9 participants
0.0844
(65.0%)
Day 8, n=9 Number Analyzed 9 participants
0.0808
(73.2%)
Day 8, PM, n=9 Number Analyzed 9 participants
0.0830
(71.7%)
28.Secondary Outcome
Title AUC (Tau) of Ritonavir Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (tau) of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM) and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
Day 1, n=10,10,0 Number Analyzed 10 participants 10 participants 0 participants
2.37
(99.5%)
2.05
(104%)
Day 8, AM, n=9,10,10 Number Analyzed 9 participants 10 participants 10 participants
9.43
(89.1%)
9.05
(62.8%)
6.76
(49.3%)
Day 8, PM, n=9,10,0 Number Analyzed 9 participants 10 participants 0 participants
9.23
(77.1%)
10.4
(52.4%)
29.Secondary Outcome
Title AUC (Tau) of Ritonavir Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (tau) of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1 and Day 8 evening dose (PM).
Time Frame Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
Day 1, n=10 Number Analyzed 10 participants
2.91
(80.4%)
Day 8 PM, n=9 Number Analyzed 9 participants
6.13
(94.3%)
30.Secondary Outcome
Title AUC (0-24) of Ritonavir Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (0-24) of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.
Time Frame Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 9 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
18.9
(80.0%)
19.5
(56.6%)
6.76
(49.3%)
31.Secondary Outcome
Title AUC (0-24) of Ritonavir Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess AUC (0-24) of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.
Time Frame Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
6.13
(94.3%)
32.Secondary Outcome
Title Accumulation Index of Ritonavir Following Q12H Dosing
Hide Description Blood samples were collected at indicated time points to assess Accumulation Index of ritonavir following Q12H dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 morning dose (AM).
Time Frame Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM
Hide Arm/Group Description:
All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 9 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of AUC
3.58
(64.0%)
4.41
(41.7%)
3.62
(39.8%)
33.Secondary Outcome
Title Accumulation Index of Ritonavir Following QHS Dosing
Hide Description Blood samples were collected at indicated time points to assess Accumulation Index of ritonavir following QHS dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 evening dose (PM).
Time Frame Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title BMS-663068 1200 mg QHS + RTV 100 mg QHS
Hide Arm/Group Description:
All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of AUC
2.19
(16.2%)
Time Frame Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days.
Adverse Event Reporting Description SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
 
Arm/Group Title BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Hide Arm/Group Description All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8. All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8. All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8. All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8. All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
All-Cause Mortality
BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BMS-663068 600 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg QHS + RTV 100 mg QHS BMS-663068 1200 mg Q12H + RTV 100 mg Q12H BMS-663068 1200 mg Q12H + RTV 100 mg QAM BMS-663068 1200 mg Q12H
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)   5/10 (50.00%)   9/10 (90.00%)   8/10 (80.00%)   9/10 (90.00%) 
Cardiac disorders           
PALPITATIONS  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Eye disorders           
EYE PRURITUS  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders           
ABDOMINAL PAIN  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
DIARRHOEA  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  2/10 (20.00%) 
NAUSEA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
TOOTHACHE  1  0/10 (0.00%)  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  0/10 (0.00%) 
General disorders           
ASTHENIA  1  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
CHEST PAIN  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
DISCOMFORT  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
FATIGUE  1  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  0/10 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Infections and infestations           
ABSCESS JAW  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
GONORRHOEA  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
NASOPHARYNGITIS  1  1/10 (10.00%)  0/10 (0.00%)  3/10 (30.00%)  2/10 (20.00%)  0/10 (0.00%) 
RHINITIS  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders           
ARTHRALGIA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
BACK PAIN  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
FLANK PAIN  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
MYALGIA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
PAIN IN EXTREMITY  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
Nervous system disorders           
DIZZINESS  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
HEADACHE  1  4/10 (40.00%)  3/10 (30.00%)  4/10 (40.00%)  3/10 (30.00%)  4/10 (40.00%) 
NEURALGIA  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
PRESYNCOPE  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
SYNCOPE  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
Psychiatric disorders           
DISORIENTATION  1  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  2/10 (20.00%) 
LISTLESS  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Renal and urinary disorders           
MICTURITION URGENCY  1  1/10 (10.00%)  1/10 (10.00%)  1/10 (10.00%)  1/10 (10.00%)  3/10 (30.00%) 
Respiratory, thoracic and mediastinal disorders           
DYSPNOEA  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders           
BLISTER  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
DRY SKIN  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
ERYTHEMA  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  2/10 (20.00%)  1/10 (10.00%) 
HYPERHIDROSIS  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
PRURITUS  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
RASH  1  2/10 (20.00%)  1/10 (10.00%)  2/10 (20.00%)  1/10 (10.00%)  2/10 (20.00%) 
RASH PRURITIC  1  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01009814    
Other Study ID Numbers: 206267
AI438-006 ( Other Identifier: Bristol-Myers Squibb )
First Submitted: November 6, 2009
First Posted: November 9, 2009
Results First Submitted: December 13, 2019
Results First Posted: January 3, 2020
Last Update Posted: January 3, 2020