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

Completed · Phase 1

Conditions studied: Infection, Human Immunodeficiency Virus

In brief

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

Key facts

Study ID

NCT02666053

Run by

ViiV Healthcare

People needed

72

Starts

2016-01-27

Expected to finish

2016-02-22

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.