Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination
- Registration Number
- NCT02342067
- Lead Sponsor
- Tobira Therapeutics, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (Cenicriviroc, PGZ, CVC+PGZ) Cenicriviroc 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 2 (Pioglitazone, CVC, CVC+PGZ) Pioglitazone 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Changes from Baseline in Vital Signs 40 days Evaluate changes from baseline in vital signs, including blood pressure and pulse rate
Evaluation of Adverse Events 40 days Evaluate adverse events
Changes from Baseline in 12-lead ECGs 40 days Evaluate changes from baseline in 12-lead ECGs
Changes from Baseline in Physical Examinations 40 days Evaluate changes from baseline in physical examinations
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)
Trial Locations
- Locations (1)
DaVita Clinical Research
🇺🇸Lakewood, Colorado, United States