A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176

Official Title
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A Two-way Drug Interaction Study to Evaluate the Effect of BMS-955176 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Dolutegravir
* Drug: BMS955176


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Target population: Healthy males and females. Women of child bearing potential (WOCBP) with negative serum pregnancy test Women must not be breastfeeding Men and WOCBP must agree to follow instructions for contraception Exclusion Criteria: History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia History of frequent headaches or acute diarrhoea. Any major surgery within 4 weeks of study drug administration Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population History of allergy to HIV maturation and integrase inhibitors,or related compounds History of smoking

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single DTG tablet under fed conditions for a specified period | Drug: Dolutegravir<br>* Dolutegravir<br>|
| Experimental: Treatment B<br>Two BMS955176 tablets under fed conditions for a specified period | Drug: BMS955176<br>* BMS955176<br>|
| Experimental: Treatment C<br>Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period | Drug: Dolutegravir<br>* Dolutegravir<br>Drug: BMS955176<br>* BMS955176<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) for DTG |  | Days 1 to 5 and days 15 to 21 | 
| Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG |  | Days 1 to 5 and days 15 to 21 | 
| Maximum observed plasma concentration (Cmax) for BMS-955176 |  | Days 8-21 | 
| Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176 |  | Days 8-21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | The incidence of observed AEs will be tabulated and reviewed for potential significance and clinical importance. | Days 1-21; for SAEs up to 30 days post discontinuation of dosing |