Clinical trial NCT02342067: Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination
Official title: A Phase 1, Multiple-Dose, Open-Label, Randomized, Crossover Study in Healthy Subjects to Assess the Effect of Pioglitazone (PGZ) on the Pharmacokinetics (PK) of Cenicriviroc Mesylate (CVC) and the Effect of CVC on the PK of PGZ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tobira Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Pharmacokinetic Assessment of CVC, as measured by Cmax, Cmin and AUC
timeFrame: Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40
measure: Pharmacokinetic Assessment of PGZ, as measured by Cmax, Cmin and AUC
timeFrame: 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:
measure: Evaluation of Adverse Events
timeFrame: 40 days
measure: Changes from Baseline in Clinical Laboratory Tests
timeFrame: 40 days
measure: Changes from Baseline in 12-lead ECGs
timeFrame: 40 days
measure: Changes from Baseline in Vital Signs
timeFrame: 40 days
measure: Changes from Baseline in Physical Examinations
timeFrame: 40 days
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research
state: Colorado
Study officials:
References: