NCT02342067

Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination

A Phase 1, Multiple-Dose, Open-Label, Randomized, Crossover Study in Healthy Subjects to Assess the Effect of Pioglitazone (PGZ) on the Pharmacokinetics (PK) of Cenicriviroc Mesylate (CVC) and the Effect of CVC on the PK of PGZ

• 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

A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK of PGZ administered with and without CVC.

Detailed description

This is a open-label, fixed-sequence, 3-period study being conducted in a single center to evaluate the following: * PK of CVC administered with and without PGZ * PK of PGZ administered with and without CVC * Safety of CVC administered with and without PGZ * Tolerability of CVC administered with and without PGZ

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cenicriviroc	CVC 150 mg QD on Days 1-10, washout on Days 11-20, PGZ 45 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40
DRUG	Pioglitazone	PGZ 45 mg QD on Days 1-10, washout on Days 11-20, CVC 150 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2015-01-19
• Last updated: 2015-05-12

Locations

1 site across 1 country: United States