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

NCT ID: NCT02342067

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (Cenicriviroc, PGZ, CVC+PGZ)

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

Group Type: EXPERIMENTAL

Cenicriviroc

Intervention Type: DRUG

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

Group 2 (Pioglitazone, CVC, CVC+PGZ)

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

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

CVC 150 mg; PGZ 45 mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tobira Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DaVita Clinical Research

Lakewood, Colorado, United States

Countries

United States

Other Identifiers

652-1-122

Identifier Type: -

Identifier Source: org_study_id