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Completed

NCT Number: NCT02342067

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cenicriviroc

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

Other names: CVC 150 mg

pioglitazone

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

Other names: PGZ 45 mg

Primary outcomes

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

    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

    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.

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

    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

    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 outcomes

  1. Evaluation of Adverse Events

    Time frame: 40 days

    Evaluate adverse events

  2. Changes from Baseline in Clinical Laboratory Tests

    Time frame: 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)

  3. Changes from Baseline in 12-lead ECGs

    Time frame: 40 days

    Evaluate changes from baseline in 12-lead ECGs

  4. Changes from Baseline in Vital Signs

    Time frame: 40 days

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

  5. Changes from Baseline in Physical Examinations

    Time frame: 40 days

    Evaluate changes from baseline in physical examinations

Sponsors and collaborators

Lead sponsor

Tobira Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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