Healthy
Conditions
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
Interventions
DRUGCenicriviroc
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
DRUGPioglitazone
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
Sponsors
Tobira Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Assessment of CVC, as measured by Cmax, Cmin and AUC | Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40 | 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. |
| Pharmacokinetic Assessment of PGZ, as measured by Cmax, Cmin and AUC | Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from Baseline in 12-lead ECGs | 40 days | Evaluate changes from baseline in 12-lead ECGs |
| Evaluation of Adverse Events | 40 days | Evaluate adverse events |
| Changes from Baseline in Physical Examinations | 40 days | Evaluate changes from baseline in physical examinations |
| Changes from Baseline in Vital Signs | 40 days | Evaluate changes from baseline in vital signs, including blood pressure and pulse rate |
| Changes from Baseline in Clinical Laboratory Tests | 40 days | 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) |
Countries
United States
Outcome results
None listed