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

Study Overview
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Brief Summary
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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
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Brief title: drug-drug interaction (DDI) Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Official Title
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Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-663068
* Drug: Darunavir (DRV)
* Drug: Ritonavir (RTV)
* Drug: Etravirine (ETR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: BMS-663068+DRV/RTV<br>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 | Drug: BMS-663068<br>* BMS-663068<br>Drug: Darunavir (DRV)<br>* Darunavir (DRV)<br>* Other names: Prezista;Drug: Ritonavir (RTV)<br>* Ritonavir (RTV)<br>* Other names: Norvir;|
| Experimental: Cohort 2: BMS-663068+ETR<br>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 | Drug: BMS-663068<br>* BMS-663068<br>Drug: Etravirine (ETR)<br>* Etravirine (ETR)<br>* Other names: Intelence;|
| Experimental: Cohort 3: BMS-663068+DRV/RTV+ETR<br>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 | Drug: BMS-663068<br>* BMS-663068<br>Drug: Darunavir (DRV)<br>* Darunavir (DRV)<br>* Other names: Prezista;Drug: Ritonavir (RTV)<br>* Ritonavir (RTV)<br>* Other names: Norvir;Drug: Etravirine (ETR)<br>* Etravirine (ETR)<br>* Other names: Intelence;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| 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 |