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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-05-31

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

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Treatment A

Single DTG tablet under fed conditions for a specified period

Group Type EXPERIMENTAL

Dolutegravir

Intervention Type DRUG

Dolutegravir

Treatment B

Two BMS955176 tablets under fed conditions for a specified period

Group Type EXPERIMENTAL

BMS955176

Intervention Type DRUG

BMS955176

Treatment C

Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period

Group Type EXPERIMENTAL

Dolutegravir

Intervention Type DRUG

Dolutegravir

BMS955176

Intervention Type DRUG

BMS955176

Interventions

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Dolutegravir

Intervention Type DRUG

BMS955176

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Women of child bearing potential (WOCBP) with negative serum pregnancy test
4. Women must not be breastfeeding
5. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria

1. History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
2. History of frequent headaches or acute diarrhoea.
3. Any major surgery within 4 weeks of study drug administration
4. 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
5. History of allergy to HIV maturation and integrase inhibitors,or related compounds
6. History of smoking

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes