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A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

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ClinicalTrials.gov Identifier: NCT00348673
Recruitment Status : Completed
First Posted : July 6, 2006
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-1
Intervention Drug: UK-453,061
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) Placebo Once/Twice Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo Once/Twice Daily (Stage 2)
Hide Arm/Group Description UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1. Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1. Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2. Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2. Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2. Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Period Title: Stage 1
Started 6 6 7 6 4 0 0 0 0
Treated 6 6 6 6 4 0 0 0 0
Completed 6 6 6 6 4 0 0 0 0
Not Completed 0 0 1 0 0 0 0 0 0
Reason Not Completed
Randomized but not Treated             0             0             1             0             0             0             0             0             0
Period Title: Stage 2
Started 0 0 0 0 0 6 6 6 2
Completed 0 0 0 0 0 6 6 6 2
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo Total
Hide Arm/Group Description UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1. Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2. Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2. Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2. Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 6 6 48
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
38.8  (8.4) 38.2  (8.6) 33.5  (8.6) 41.7  (4.1) 29.2  (7.9) 40.3  (7.5) 37.0  (8.5) 33.8  (8.0) 36.6  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
48
 100.0%
1.Primary Outcome
Title Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8
Hide Description Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.
Time Frame Baseline, Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo
Hide Arm/Group Description:
UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Baseline 4.57  (0.33) 4.39  (0.48) 4.41  (0.27) 4.38  (0.17) 4.65  (0.46) 4.55  (0.45) 4.70  (0.33) 4.57  (0.49)
Change at Day 8 -0.30  (0.20) -0.78  (0.45) -1.33  (0.38) -1.67  (0.19) -1.79  (0.32) -1.62  (0.22) -0.92  (0.38) 0.01  (0.16)
2.Secondary Outcome
Title Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
Hide Description Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported.
Time Frame Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo
Hide Arm/Group Description:
UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Measure Type: Number
Unit of Measure: participants
2 days 0 1 0 0 0 0 0 2
4 days 2 1 0 0 0 0 1 0
7 days 2 1 1 0 0 0 0 1
13 days 1 2 4 3 3 1 0 0
21 days 0 0 0 1 0 1 1 0
31 to 33 days (follow-up) 1 0 0 1 1 1 1 1
3.Other Pre-specified Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)
Hide Description AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen.
Time Frame 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2)
Hide Arm/Group Description:
UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram*hour/milliliter (ng*hr/mL)
47.2  (21.87) 150.0  (51.57) 686.7  (378.56) 3543.5  (818.85) 6530.1  (963.97) 4719.4  (744.83) 863.1  (260.83)
4.Other Pre-specified Outcome
Title Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2)
Hide Arm/Group Description:
UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
14.6  (4.50) 42.6  (20.31) 146.6  (120.07) 490.2  (248.68) 1245.3  (560.17) 979.1  (247.79) 172.4  (51.53)
5.Other Pre-specified Outcome
Title Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2)
Hide Arm/Group Description:
UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hrs
1.0
(1 to 3)
1.0
(1 to 3)
2.0
(1 to 4)
3.0
(2 to 6)
2.0
(1 to 3)
1.5
(1 to 3)
2.0
(1 to 3)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo
Hide Arm/Group Description UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1. Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2. Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2. Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2. Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
All-Cause Mortality
UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Renal and urinary disorders                 
Nephrolithiasis * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 750 mg Once Daily (Stage 2) UK-453,061 500 mg Twice Daily (Stage 2) UK-453,061 100 mg Once Daily (Stage 2) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   5/6 (83.33%)   5/6 (83.33%)   5/6 (83.33%)   6/6 (100.00%)   6/6 (100.00%)   3/6 (50.00%)   4/6 (66.67%) 
Blood and lymphatic system disorders                 
Thrombocytopenia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Cardiac disorders                 
Tachycardia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders                 
Ear pain * 1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vertigo * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Eye disorders                 
Chloropsia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders                 
Abdominal discomfort * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Abdominal distension * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%) 
Abdominal pain upper * 1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Abnormal faeces * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Aphthous stomatitis * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Constipation * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Diarrhoea * 1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Dyspepsia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Flatulence * 1  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Lip dry * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nausea * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%) 
Toothache * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vomiting * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders                 
Fatigue * 1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%) 
Feeling cold * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Malaise * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders                 
Hepatic cyst * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations                 
Anal chlamydia infection * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Anogenital warts * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Cystitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Herpes simplex * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Herpes zoster * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Influenza * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nasopharyngitis * 1  0/6 (0.00%)  3/6 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%) 
Oral herpes * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Pharyngitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Tonsillitis * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Urethritis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Investigations                 
Hepatic enzyme increased * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Protein total increased * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                 
Anorexia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Osteoarthritis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders                 
Balance disorder * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dizziness postural * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Headache * 1  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  2/6 (33.33%)  3/6 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Motor dysfunction * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Paraesthesia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Sciatica * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Sensory disturbance * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Syncope * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders                 
Agitation * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Disorientation * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders                 
Haematuria * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Ketonuria * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%) 
Pollakiuria * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders                 
Prostatitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders                 
Epistaxis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders                 
Hyperhidrosis * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Night sweats * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%) 
Rash * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Xeroderma * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Vascular disorders                 
Aortic arteriosclerosis * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hot flush * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Hypertension * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypotension * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Phlebolith * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v10.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00348673     History of Changes
Other Study ID Numbers: A5271010
First Submitted: July 5, 2006
First Posted: July 6, 2006
Results First Submitted: August 14, 2013
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013