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

Completed · Phase 1

Conditions studied: Infection, Human Immunodeficiency Virus

In brief

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

Key facts

Study ID

NCT02715479

Run by

ViiV Healthcare

People needed

14

Starts

2016-04-01

Expected to finish

2016-05-01

Last updated by the study team

2017-01-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.