Food Effect Study With BMS-955176
An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2014
CompletedStudy Start
First participant enrolled
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2016
CompletedApril 17, 2017
April 1, 2017
1.8 years
October 10, 2014
April 13, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Maximum observed plasma concentration (Cmax) for BMS-955176
Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176
Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176
Up to Day 4 of Period 4
Plasma concentration at 24 hours post-dose (C24) for BMS-955176
Up to Day 4 of Period 4
Secondary Outcomes (1)
Safety and tolerability
Up to 30 days post discontinuation of dosing
Study Arms (21)
Arm 1 (ABDC): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 2 (BCAD): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 3 (CDBA): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 4 (DACB): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 5 (EFHG): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 6 (FGEH): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 7 (GHFE): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 8 (HEGF): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 9 (IJK): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 10 (JKI): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 11 (KIJ): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 12 (IKJ): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 13 (JIK): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 14 (KJI): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 15 (LMN): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 16 (OPQ): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 17 (PQO): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 18 (QOP): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 19 (OQP): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 20 (POQ): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 21 (QPO): BMS-955176
EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Interventions
Single dose by mouth for each treatment specified
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 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
Ruddington Fields, Nottinghamshire, 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
October 10, 2014
First Posted
October 24, 2014
Study Start
October 23, 2014
Primary Completion
August 15, 2016
Study Completion
August 15, 2016
Last Updated
April 17, 2017
Record last verified: 2017-04