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

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: Dolutegravir; Drug: BMS955176

• Registration Number: NCT02715479
• Lead Sponsor: ViiV Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-22
• Study Start: 2016-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment C	Dolutegravir	Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period
Treatment C	BMS955176	Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period
Treatment A	Dolutegravir	Single DTG tablet under fed conditions for a specified period
Treatment B	BMS955176	Two BMS955176 tablets under fed conditions for a specified period

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States