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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.

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
Healthy Drug: Cenicriviroc Drug: Pioglitazone 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

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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: PGZ 45 mg




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342067


Locations
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United States, Colorado
DaVita Clinical Research
Lakewood, Colorado, United States, 80228
Sponsors and Collaborators
Tobira Therapeutics, Inc.
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Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02342067    
Other Study ID Numbers: 652-1-122
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Pioglitazone
Cenicriviroc
Hypoglycemic Agents
Physiological Effects of Drugs
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents