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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02666053

First received: January 7, 2016
Last updated: September 7, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-663068
Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

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

Enrollment: 72
Study Start Date: January 27, 2016
Study Completion Date: February 22, 2016
Primary Completion Date: February 22, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02666053

Locations

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

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02666053   History of Changes  
Other Study ID Numbers: 206295  
  AI438-071  
Study First Received: January 7, 2016  
Last Updated: September 7, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.