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NCT02666053 Clinical 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

Infection, Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02666053
Other study ID # 206295
Secondary ID AI438-071
Status Completed
Phase Phase 1
First received January 7, 2016
Last updated September 7, 2017
Start date January 27, 2016
Est. completion date February 22, 2016

Study information
Verified date September 2017
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date February 22, 2016
Est. primary completion date February 22, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. Signed Informed Consent

2. Target population: Healthy males and females.

3. Males and females

4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test

5. Women must not be breastfeeding

6. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of any chronic or acute illness or gastrointestinal disease

2. Any major surgery within 4 weeks of study drug administration

3. 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.

4. History of allergy to HIV attachment inhibitors, famotidine or high fat meal

5. History of smoking

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BMS-663068
BMS-663068

Locations
Country Name City State
United States GSK Investigational Site Austin Texas

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum observed plasma concentration (Cmax) Days 1-12
Primary Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF) Days 1-12
Secondary 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. Days 1-12; for SAEs up to 30 days post discontinuation of dosing
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