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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02715479

Enrollment

Registered

2016-03-22

Start date

2016-04-30

Completion date

2016-05-31

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus

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

Interventions

DRUGDolutegravir

Dolutegravir

DRUGBMS955176

BMS955176

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026