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

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02666053
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 72
• Location: 1
• Arms: 3
• Actual Duration (Days): 26
• Patients Per Site Per Month: 84.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus	Drug: BMS-663068	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 27, 2016
• Actual Primary Completion Date: Feb 22, 2016
• Actual Study Completion Date: Feb 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A Single BMS-663068 tablet under fasted conditions	Drug: BMS-663068; BMS-663068
Experimental: Treatment B Single BMS-663068 tablet with a high fat meal	Drug: BMS-663068; BMS-663068
Experimental: Treatment C Single BMS-663068 tablet after a single famotidine tablet under fasted conditions	Drug: BMS-663068; BMS-663068

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Days 1-12]

2. Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF) [Days 1-12]

Secondary Outcome Measures

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]

   Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Austin	Texas	United States	78744

Sponsors and Collaborators

• ViiV Healthcare
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02666053
• Other Study ID Numbers: 206295; AI438-071
• First Posted: Jan 28, 2016
• Last Update Posted: Sep 11, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Fostemsavir

Study Results

No Results Posted as of Sep 11, 2017