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

September 7, 2017 updated by: ViiV Healthcare

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Days 1-12
Days 1-12
Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)
Time Frame: Days 1-12
Days 1-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation
Time Frame: 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.
Days 1-12; for SAEs up to 30 days post discontinuation of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2016

Primary Completion (Actual)

February 22, 2016

Study Completion (Actual)

February 22, 2016

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206295
  • AI438-071 (Other Identifier: Bristol-Myers Squibb)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection, Human Immunodeficiency Virus

Clinical Trials on BMS-663068

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe