Clinical Trials Directory

Trials / Completed

CompletedNCT02164045

Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529

Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529 From an Extended-Release Formulation of BMS-663068 in Healthy Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
38 (actual)
Sponsor
ViiV Healthcare · Industry
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

The current food effect study is being performed to support a Phase 3 study with BMS 663068. Results from this study will inform whether patients in the upcoming Phase 3 study can be given the flexibility to dose BMS-663068 in the fasted state, if so desired.

Detailed description

Primary Purpose: Other: To assess the effect of food on the steady-state exposure of BMS-626529 when administered as BMS 663068 600 mg twice daily (BID) to healthy subjects Acquired Immune Deficiency Syndrome (AIDS)

Conditions

Interventions

TypeNameDescription
DRUGBMS-663068BMS-663068

Timeline

Start date
2014-06-24
Primary completion
2014-07-25
Completion
2014-07-25
First posted
2014-06-16
Last updated
2017-07-27

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02164045. Inclusion in this directory is not an endorsement.