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

Sponsor
Tobira Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02342067
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
4
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 (Cenicriviroc, PGZ, CVC+PGZ)

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

Drug: Cenicriviroc
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

    		•
    Experimental: Group 2 (Pioglitazone, CVC, CVC+PGZ)

    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

    Drug: Pioglitazone
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. Evaluation of Adverse Events [40 days]

      Evaluate adverse events

    2. 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)

    3. Changes from Baseline in 12-lead ECGs [40 days]

      Evaluate changes from baseline in 12-lead ECGs

    4. Changes from Baseline in Vital Signs [40 days]

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

    5. Changes from Baseline in Physical Examinations [40 days]

      Evaluate changes from baseline in physical examinations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DaVita Clinical Research Lakewood Colorado United States 80228

    Sponsors and Collaborators

    • Tobira Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tobira Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02342067
    Other Study ID Numbers:
    • 652-1-122
    First Posted:
    Jan 19, 2015
    Last Update Posted:
    May 12, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Pioglitazone
    Cenicriviroc

    Study Results

    No Results Posted as of May 12, 2015