A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects
2 other identifiers
interventional
72
1 country
1
Brief Summary
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2016
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
January 7, 2016
CompletedStudy Start
First participant enrolled
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2016
CompletedSeptember 11, 2017
September 1, 2017
26 days
January 7, 2016
September 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum observed plasma concentration (Cmax)
Days 1-12
Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)
Days 1-12
Secondary Outcomes (1)
Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation
Days 1-12; for SAEs up to 30 days post discontinuation of dosing
Study Arms (3)
Treatment A
EXPERIMENTALSingle BMS-663068 tablet under fasted conditions
Treatment B
EXPERIMENTALSingle BMS-663068 tablet with a high fat meal
Treatment C
EXPERIMENTALSingle BMS-663068 tablet after a single famotidine tablet under fasted conditions
Interventions
Eligibility Criteria
You may qualify if:
- Signed Informed Consent
- Target population: Healthy males and females.
- Males and females
- Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
- Women must not be breastfeeding
- Men and WOCBP must agree to follow instructions for contraception
You may not qualify if:
- History of any chronic or acute illness or gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- History of allergy to HIV attachment inhibitors, famotidine or high fat meal
- History of smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (1)
GSK Investigational Site
Austin, Texas, 78744, United States
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
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2016
First Posted
January 28, 2016
Study Start
January 27, 2016
Primary Completion
February 22, 2016
Study Completion
February 22, 2016
Last Updated
September 11, 2017
Record last verified: 2017-09