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

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.

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

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