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A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

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ClinicalTrials.gov Identifier: NCT00546715
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : September 10, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Daclatasvir
Drug: Placebo
Enrollment 95
Recruitment Details The study was conducted at 7 centers in United States.
Pre-assignment Details A total of 95 participants were enrolled, of which 18 received treatment. Remaining 77 participants were not randomized (participants either no longer met study criteria by the time of randomization or were no longer needed as an adequate number of study participants had already been dosed in each dose panel).
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Period Title: Overall Study
Started 6 5 5 2
Completed 6 4 5 2
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo Total
Hide Arm/Group Description Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Total of all reporting groups
Overall Number of Baseline Participants 6 5 5 2 18
Hide Baseline Analysis Population Description
The analysis was performed in the safety population defined as all participants who received any study drug treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 5 participants 2 participants 18 participants
43.5
(31 to 48)
46
(23 to 49)
44
(32 to 45)
28
(22 to 34)
44
(22 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 5 participants 2 participants 18 participants
Female
1
  16.7%
3
  60.0%
4
  80.0%
0
   0.0%
8
  44.4%
Male
5
  83.3%
2
  40.0%
1
  20.0%
2
 100.0%
10
  55.6%
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
Hide Description AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding) or disease which either occurs during study, whether or not related to the study drug. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Time Frame Day 1 up to Day 7 for non-SAEs and Day 1 to 30 days after study discontinuation for SAEs
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed in safety population defined as all participants who received any study drug treatment.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5 2
Measure Type: Number
Unit of Measure: participants
SAEs 0 0 0 0
Discontinuations due to AEs 0 0 0 0
Death 0 0 0 0
2.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings
Hide Description Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion.
Time Frame Day 1 up to Day 7 or Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the safety population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5 2
Measure Type: Number
Unit of Measure: participants
Systolic blood pressure 0 0 0 0
Diastolic blood pressure 0 0 0 0
Pulse rate 0 0 0 0
Respiration rate 0 0 0 0
Temperature 0 0 0 0
Weight 0 0 0 0
3.Primary Outcome
Title Number of Participants With Marked Abnormalities in Laboratory Findings
Hide Description Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*pre-treatment value, Leukocytes (low) as <0.9*lower limit of normal, Aspartate Aminotransferase (high) as >1.25*upper limit of normal, Creatinine (high) as >1.33*pre-treatment value, Bicarbonate (high) as >1.2*upper limit of normal, Total Protein (high) as >1.1*upper limit of normal, Creatinine Kinase (high) as >1.5*upper limit of normal, Blood in Urine (high) as ≥ 2*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests.
Time Frame Day 1 up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the safety population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5 2
Measure Type: Number
Unit of Measure: participants
Hematocrit (Low) 1 0 0 0
Leukocytes (Low) 0 0 1 0
Aspartate Aminotransferase (High) 1 0 0 0
Creatinine (High) 1 1 1 1
Bicarbonate (High) 0 1 0 0
Total Protein (High) 1 0 1 0
Creatinine Kinase (High) 1 0 0 0
Blood in Urine (High) 0 0 1 0
4.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24)
Hide Description Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. C-12 and C-24 were defined as observed plasma concentration of daclatasvir at 12 hours and 24 hours, respectively. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the pharmacokinetic (PK) set population defined as all participants who received at least single dose of daclatasvir with available valid data.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cmax
15.7
(56%)
177.6
(52%)
2416.5
(27%)
C-12
2.7
(49%)
32.2
(28%)
706.7
(51%)
C-24
1.1
(65%)
14.2
(44%)
363.2
(55%)
5.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time
Hide Description Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. It was calculated as the sum of linear trapezoids using non-compartmental analysis. Area under the plasma concentration-time curve from time zero extrapolated to infinite time was estimated as sum of AUC(0-T) and the extrapolated area, computed by the quotient of the last observable concentration and λ, where λ was the slopes of the terminal phases of the plasma concentration-time profiles. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the PK set population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
AUC(0-T)
126.8
(49%)
1413.9
(45%)
28239.1
(48%)
AUC(0-INF)
129.1
(49%)
1431.1
(45%)
29256.1
(53%)
6.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax)
Hide Description Tmax was defined as the time required to reach maximum observed plasma concentration. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the PK set population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5
Median (Full Range)
Unit of Measure: hours
1
(0.5 to 3)
1
(1 to 1.5)
1.5
(1 to 3)
7.Secondary Outcome
Title Plasma Half-life (T-half)
Hide Description Plasma half-life was defined as the time required for one half of the total amount of administered drug eliminated from the body. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the PK set population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5
Mean (Standard Deviation)
Unit of Measure: hours
9.7  (2.65) 12.1  (1.97) 14.0  (6.43)
8.Secondary Outcome
Title Apparent Total Body Clearance (CLT/F)
Hide Description Apparent total body clearance (CLT/F) was calculated as Dose/AUC(INF), where CLT was the clearance of the drug and F was the absolute oral bioavailability. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the PK set population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
129.1
(48%)
116.5
(43%)
57.0
(49%)
9.Secondary Outcome
Title Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Hide Description The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Positive value indicated reduction from baseline in HCV RNA while negative value indicated an increase from baseline in HCV RNA. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.
Time Frame Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the pharmacodynamic (PD) population defined as participants who received at least one dose of study medication with available valid data.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 5 5 5 2
Mean (Standard Deviation)
Unit of Measure: log IU/mL
Decline From Baseline to 24 hours 2.12  (0.57) 3.24  (0.51) 3.28  (0.35) -0.12  (0.29)
Maximum Decline 2.44  (0.80) 3.12  (0.66) 4.06  (0.53) 0.06  (0.11)
10.Secondary Outcome
Title Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline
Hide Description Participants were assessed for time to reach maximum decrease in log10 hepatitis C virus RNA level. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.
Time Frame Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the PD population defined as participants who received at least one dose of study medication with available valid data.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 5 5 5 2
Mean (Standard Deviation)
Unit of Measure: hours
16.4  (7.8) 43.2  (56.74) 105.60  (55.25) 144  (0)
11.Secondary Outcome
Title Change From Baseline in Heart Rate to Day 7 or Discharge
Hide Description Changes in heart rate from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The normal heart rate lies between 60-90 beats per minute (bpm), below 60 bpm and above 90 bpm were considered as bradycardia and tachycardia, respectively.
Time Frame Baseline (Day 1), Day 7 or Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the safety population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5 2
Mean (Standard Deviation)
Unit of Measure: bpm
7.3  (16.2) 7.6  (9.3) 1.6  (8.5) 14  (1.4)
12.Secondary Outcome
Title Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge
Hide Description The ECG was recorded after the participant was in a supine position for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. QTc was defined as corrected QT interval at a heart rate of 60 bpm. QTc was estimated using Bazett’s formula and Fredericia’s formula.
Time Frame Baseline (Day 1), Day 7 or Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the safety population.
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 6 5 5 2
Mean (Standard Deviation)
Unit of Measure: msec
QT Interval -27.5  (32.7) -18.6  (29.2) -1.2  (27.8) -36  (14.1)
QTc Fridericia Interval -13.3  (10.5) -5.6  (14.7) 0.4  (11.4) -12.5  (19.1)
QTc Bazett Interval -5.5  (21.0) 1.2  (12.7) 1.8  (7.2) 1  (21.2)
QRS Width -2.3  (4.7) 1  (11.3) -3.6  (8.2) 0  (0)
PR Interval -6.7  (9.9) 2.4  (10.3) -4.4  (11.2) -7  (7.1)
13.Secondary Outcome
Title Change From Baseline in Blood Pressure to Day 7 or Discharge
Hide Description Changes in blood pressure from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement.
Time Frame Baseline (Day 1), Day 7 or Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description:
Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Overall Number of Participants Analyzed 5 4 3 1
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic blood pressure 9.6  (7.3) 4.3  (5.9) 3.7  (12.7) 1 [1]   (NA)
Systolic blood pressure 14  (4.4) 1  (15.7) 6  (17.5) -2 [1]   (NA)
[1]
Only 1 participant was available for assessment, hence value of standard deviation is not applicable.
Time Frame Day 1 up to Day 7 (for non-SAEs), Day 1 to 30 days after study discontinuation (for SAEs)
Adverse Event Reporting Description On-treatment period
 
Arm/Group Title Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Hide Arm/Group Description Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose. Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
All-Cause Mortality
Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir-1 mg Daclatasvir-10 mg Daclatasvir-100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   3/5 (60.00%)   1/5 (20.00%)   0/2 (0.00%) 
Gastrointestinal disorders         
Flatulence  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/2 (0.00%) 
Abdominal pain  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Nausea  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Diarrhoea  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/2 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal pain  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/2 (0.00%) 
Nervous system disorders         
Headache  1  2/6 (33.33%)  2/5 (40.00%)  0/5 (0.00%)  0/2 (0.00%) 
Paraesthesia  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Memory impairment  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Psychiatric disorders         
Abnormal dreams  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Nasal congestion  1  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial’s primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546715     History of Changes
Other Study ID Numbers: AI444-002
First Submitted: October 17, 2007
First Posted: October 19, 2007
Results First Submitted: August 10, 2015
Results First Posted: September 10, 2015
Last Update Posted: November 18, 2015