Back to resultsA 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
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663068
Sponsored by
About this trial
This is an interventional other trial for Infection, Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Single BMS-663068 tablet under fasted conditions
Single BMS-663068 tablet with a high fat meal
Single BMS-663068 tablet after a single famotidine tablet under fasted conditions
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)
Secondary Outcome Measures
Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation
Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment.
Full Information
NCT ID
NCT02666053
First Posted
January 7, 2016
Last Updated
September 7, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02666053
Brief Title
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
Official Title
A Study to Assess the Effect of a High-fat Meal and Increased Gastric pH on the Bioavailability of an Extended-release Formulation of BMS-663068 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 27, 2016 (Actual)
Primary Completion Date
February 22, 2016 (Actual)
Study Completion Date
February 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Single BMS-663068 tablet under fasted conditions
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Single BMS-663068 tablet with a high fat meal
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
Single BMS-663068 tablet after a single famotidine tablet under fasted conditions
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
BMS-663068
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Days 1-12
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)
Time Frame
Days 1-12
Secondary Outcome Measure Information:
Title
Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation
Description
Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment.
Time Frame
Days 1-12; for SAEs up to 30 days post discontinuation of dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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