NCT01827540

Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam

A Phase I, Multiple-Dose, Open-Label, Crossover Study in Healthy Subjects to Assess the Effect of Dolutegravir (DTG) on the Pharmacokinetics (PK) of Cenicriviroc (CVC) and the Effect of CVC on the PK of DTG and on a Single Dose of Midazolam

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tobira Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.

Detailed description

Primary Objectives * To evaluate the steady-state PK of CVC administered with and without DTG . * To evaluate the steady-state PK of DTG administered with and without CVC . * To evaluate the PK of a single dose of Midazolam administered with and without steady state CVC when both are administered orally. Secondary Objectives * To evaluate the safety and tolerability of CVC administered with and without DTG. * To evaluate the safety and tolerability of CVC administered with and without Midazolam.

Conditions

• HIV-infection/AIDS

Interventions

Type	Name	Description
DRUG	Cenicriviroc
DRUG	Dolutegravir
DRUG	Midazolam

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-04-09
• Last updated: 2014-04-09

Locations

1 site across 1 country: United States