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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: Dolutegravir; Drug: BMS955176

Study type: Interventional

Funder types: Industry

Identifiers

NCT02715479

206222

AI468-052 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 3 patient groups

Treatment A

Experimental group

Description:

Single DTG tablet under fed conditions for a specified period

Treatment:

Drug: Dolutegravir

Treatment B

Experimental group

Description:

Two BMS955176 tablets under fed conditions for a specified period

Treatment:

Drug: BMS955176

Treatment C

Experimental group

Description:

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

Treatment:

Drug: BMS955176

Drug: Dolutegravir