Clinical trial NCT02063360: DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
Official title: Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2014-02-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Brief title: drug-drug interaction (DDI)

Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Eligibility 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-626529
timeFrame: 20 timepoints up to day 26
measure: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529
timeFrame: 20 timepoints up to day 26
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR
timeFrame: Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
measure: Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR
timeFrame: Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
measure: Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR
timeFrame: Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
measure: Cmax for DRV, RTV, and ETR
timeFrame: 24 timepoints up to 26 day
measure: AUC(TAU) for DRV, RTV, and ETR
timeFrame: 24 timepoints up to 26 day
measure: Safety and tolerability endpoints include incidence of adverse event (AEs), serious adverse event (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead ECGs
timeFrame: Up to day 27
Other outcomes:
Locations:
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Moore K, Thakkar N, Magee M, Sevinsky H, Vakkalagadda B, Lubin S, Llamoso C, Ackerman P. Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants. Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0225121. doi: 10.1128/aac.02251-21. Epub 2022 Mar 22.