DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

• Status: Completed
• Trial end date: 2014-05-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Darunavir; Etravirine; Fostemsavir; Ritonavir

Criteria

Inclusion Criteria:

• Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests

• Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception

Exclusion Criteria:

• Any significant acute or chronic medical condition

• Unable to tolerate oral medications

• Inability to be venipunctured and/or tolerate venous access

• Current or recent (within 3 months of dosing) gastrointestinal disease

• Abnormal liver function test