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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tobira Therapeutics, Inc.
• Treatments: Cenicriviroc; Pioglitazone; TAK-652

Criteria

Inclusion Criteria:

• Provide written informed consent

• BMI ≥ 18 and ≤ 35 kg/m2

• No clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations, and 12-lead ECG

• Agree to comply with the study procedures and restrictions

Exclusion Criteria:

• Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant conditions as determined by the investigator

• History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy

• Serum ALT, AST or bilirubin ≥ grade 1 (ALT and AST > ULN - 3.0 x ULN; bilirubin > ULN
• 1.5 x ULN) at screening

• Positive for HIV, HBV or HCV infection

• Use of any prescription drugs or prohibited medications within 30 days from the first dose of the study medication

• Use of alcohol-containing or caffeine-containing foods or beverages within 72 hours prior to the first dose of study medication