Relative Bioavailability Study With BMS-955176
Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects
3 other identifiers
interventional
47
1 country
1
Brief Summary
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2014
CompletedStudy Start
First participant enrolled
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2014
CompletedSeptember 11, 2017
September 1, 2017
3 months
March 21, 2014
September 7, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax) of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Secondary Outcomes (4)
Time of maximum observed plasma concentration (Tmax) of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Terminal plasma half-life (T-HALF) of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Apparent total body clearance (CLT/F) of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations
Up to Period 4/Day 4 (discharge)
Study Arms (8)
Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)
EXPERIMENTALBMS-955176 single dose by mouth as specified
Interventions
BMS-955176
Eligibility Criteria
You may qualify if:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / \[height (m)\]2
- Men and women, ages 18 to 50 years, inclusive
- Women must not be of childbearing potential, must not be breastfeeding
You may not qualify if:
- Any significant acute or chronic medical illness
- History of cardiac disease or clinically significant cardiac arrhythmias
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (1)
GSK Investigational Site
Nottingham, NG11 6JS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2014
First Posted
March 26, 2014
Study Start
March 25, 2014
Primary Completion
July 7, 2014
Study Completion
July 7, 2014
Last Updated
September 11, 2017
Record last verified: 2017-09