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Trial record 11 of 19 for:    Cenicriviroc

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

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ClinicalTrials.gov Identifier: NCT02342067
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 12, 2015
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE December 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
  • Evaluation of Adverse Events [ Time Frame: 40 days ]
    Evaluate adverse events
  • 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)
  • Changes from Baseline in 12-lead ECGs [ Time Frame: 40 days ]
    Evaluate changes from baseline in 12-lead ECGs
  • Changes from Baseline in Vital Signs [ Time Frame: 40 days ]
    Evaluate changes from baseline in vital signs, including blood pressure and pulse rate
  • Changes from Baseline in Physical Examinations [ Time Frame: 40 days ]
    Evaluate changes from baseline in physical examinations
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
  • Evaluation of Adverse Events [ Time Frame: 40 days ]
    Evaluate adverse events
  • Changes from Baseline in Clinical Laboratory Tests [ Time Frame: 40 days ]
    Evaluate changes from baseline in clinical laboratory tests (chemistry, hematology, urinalysis)
  • Changes from Baseline in 12-lead ECGs [ Time Frame: 40 days ]
    Evaluate changes from baseline in 12-lead ECGs
  • Changes from Baseline in Vital Signs [ Time Frame: 40 days ]
    Evaluate changes from baseline in vital signs
  • Changes from Baseline in Physical Examinations [ Time Frame: 40 days ]
    Evaluate changes from baseline in physical examinations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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 Name: CVC 150 mg
  • 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 Name: PGZ 45 mg
Study Arms  ICMJE
  • 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
    Intervention: Drug: Cenicriviroc
  • 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
    Intervention: Drug: Pioglitazone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342067
Other Study ID Numbers  ICMJE 652-1-122
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tobira Therapeutics, Inc.
Study Sponsor  ICMJE Tobira Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tobira Therapeutics, Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP