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

HIV-infection/AIDS Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01827540
Study type Interventional
Source Tobira Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date March 2013
Completion date May 2013
View Details
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