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

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-663068; Drug: Darunavir (DRV); Drug: Etravirine (ETR); Drug: Ritonavir (RTV)

• Registration Number: NCT02063360
• Lead Sponsor: ViiV Healthcare

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

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Primary Completion: 2014-05-01
• Study Completion: 2014-05-13
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: BMS-663068+DRV/RTV	BMS-663068	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16
Cohort 1: BMS-663068+DRV/RTV	Darunavir (DRV)	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16
Cohort 1: BMS-663068+DRV/RTV	Ritonavir (RTV)	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16
Cohort 2: BMS-663068+ETR	Etravirine (ETR)	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet ETR 200mg orally orally twice daily on days 7-16
Cohort 3: BMS-663068+DRV/RTV+ETR	Darunavir (DRV)	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16
Cohort 3: BMS-663068+DRV/RTV+ETR	Ritonavir (RTV)	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16
Cohort 3: BMS-663068+DRV/RTV+ETR	Etravirine (ETR)	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16
Cohort 2: BMS-663068+ETR	BMS-663068	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet ETR 200mg orally orally twice daily on days 7-16
Cohort 3: BMS-663068+DRV/RTV+ETR	BMS-663068	Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of BMS-626529	20 timepoints up to day 26
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529	20 timepoints up to day 26

Secondary Outcome Measures

Name	Time	Method
AUC(TAU) for DRV, RTV, and ETR	24 timepoints up to 26 day
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	Up to day 27
Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR	Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR	Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR	Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
Cmax for DRV, RTV, and ETR	24 timepoints up to 26 day