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

Tobira Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pioglitazone; Drug: Cenicriviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT02342067

652-1-122

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group 1 (Cenicriviroc, PGZ, CVC+PGZ)

Experimental group

Description:

Treatment A: CVC 150 mg QD for 10 days followed by 10-day washout Treatment B: PGZ 45 mg QD for 10 days Treatment C: co-administration of PGZ 45 mg QD + CVC 150 mg QD for 10 days

Treatment:

Drug: Cenicriviroc

Group 2 (Pioglitazone, CVC, CVC+PGZ)

Experimental group

Description:

Treatment B: PGZ 45 mg QD for 10 days followed by 10-day washout Treatment A: CVC 150 mg QD for 10 days Treatment C: co-administration of CVC 150 mg QD + PGZ 45 mg QD for 10 days

Treatment:

Drug: Pioglitazone