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

Phase 1CompletedNCT02342067

Tobira Therapeutics, Inc.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CenicrivirocDRUG

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

PioglitazoneDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

DaVita Clinical Research

Lakewood, Colorado, United States

Outcomes

Primary Outcomes

Pharmacokinetic Assessment of CVC, as measured by Cmax, Cmin and AUC

PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9, 22-29, and 32-39.

Time frame: Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40

Pharmacokinetic Assessment of PGZ, as measured by Cmax, Cmin and AUC

PK profile will be calculated based on PGZ exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9, 22-29, and 32-39.

Time frame: Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40

Secondary Outcomes

Evaluation of Adverse Events

Evaluate adverse events

Time frame: 40 days

Changes from Baseline in Clinical Laboratory Tests

Evaluate changes from baseline in clinical laboratory tests including serum chemistry (ALT, AST, BUN, cholesterol, glucose), hematology (hemoglobin, red blood cell count, white blood cell count and differential), urinalysis (pH, glucose, ketones, protein, urobilinogen)

Time frame: 40 days

Changes from Baseline in 12-lead ECGs

Evaluate changes from baseline in 12-lead ECGs

Time frame: 40 days

Changes from Baseline in Vital Signs

Evaluate changes from baseline in vital signs, including blood pressure and pulse rate

Time frame: 40 days

Changes from Baseline in Physical Examinations

Data from ClinicalTrials.gov

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