A Open-label, Drug-Drug Interaction With Maraviroc (DDI)

Study Overview
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Brief Summary
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This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.

Official Title
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A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-663068
* Drug: Maraviroc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion Exclusion Criteria: Any condition possibly affecting drug absorption Pre-existing liver dysfunction Any significant acute or chronic medical illness Orthostatic intolerance Other protocol specified exclusion criteria could apply

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential Dosing<br>Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18 | Drug: BMS-663068<br>* BMS-663068<br>Drug: Maraviroc<br>* Maraviroc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax) | PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - Cmax | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | 
| BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU) | PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - AUC(TAU) | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | 
| Maraviroc Pharmacokinetics: Cmax | PK parameters for maraviroc in the absence or presence of BMS-663068 include: - Cmax | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | 
| Maraviroc Pharmacokinetics: AUC(TAU) | PK parameters for maraviroc in the absence or presence of BMS-663068 include: - AUC(TAU) | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax) | PK parameters for BMS-626529 include: - Tmax | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | 
| Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12) | PK parameters for BMS-626529 include: - C12 | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | 
| Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose) | PK parameters for BMS-626529 include: - Ctrough (predose) | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | 
| Other PK Parameters for maraviroc: Tmax | PK Parameters for maraviroc include: -Tmax | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | 
| Other PK Parameters for maraviroc: C12 | PK Parameters for maraviroc include: C12 | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | 
| Other PK Parameters for maraviroc: Ctrough | PK Parameters for maraviroc include: - Ctrough | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | 
| Clinical Safety as Measured by Adverse Events | Adverse event monitoring | Day 1 to Day 26 | 
| Clinical Safety as Measured by Vital Signs | Vital sign measurement | Day 1 to Day 26 | 
| Clinical Safety as Measured by Electrocardiograms (ECGs) | 12-lead ECGs | Day 1 to Day 26 | 
| Clinical Safety as Measured by Physical Examination | Physical examinations | Day 1 to Day 26 | 
| Clinical Safety as Measured by Clinical Laboratory Evaluations | Clinical chemistry, hematology, urinalysis | Day 1 to Day 26 |