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Trial record 11 of 19 for:    Cenicriviroc

Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02120547
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : August 21, 2014
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 18, 2014
First Posted Date  ICMJE April 22, 2014
Last Update Posted Date August 21, 2014
Study Start Date  ICMJE March 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2014)
Multiple-dose pharmacokinetics of CVC [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14 ]
Intensive PK on Days 1 and 14. Trough PK on Days 3-13. Additional free (unbound) CVC will be assessed 2 hours and 24 hours postdose on Day 14.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2014)
Safety and tolerability [ Time Frame: Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects ]
Adverse events, concomitant medications, vital signs, 12-lead triplicate ECGs, clinical laboratory tests (chemistry, hematology, urinalysis) and physical examinations will be assessed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 18, 2014)
Pro-inflammatory cytokines and biomarkers of bacterial translocation [ Time Frame: 28 days after receiving first dose of study drug ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment
Official Title  ICMJE An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)
Brief Summary To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Liver Insufficiency
Intervention  ICMJE
  • Drug: Cenicriviroc in mild liver impaired
    Subjects with mild hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.
    Other Name: CVC
  • Drug: Cenicriviroc in moderate liver impaired
    Subjects with moderate hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.
    Other Name: CVC
Study Arms  ICMJE
  • Experimental: Cenicriviroc in mild liver impaired
    Subjects with mild liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days.
    Intervention: Drug: Cenicriviroc in mild liver impaired
  • Experimental: Cenicriviroc in moderate liver impaired
    Subjects with moderate liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days.
    Intervention: Drug: Cenicriviroc in moderate liver impaired
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: August 19, 2014)
31
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2014)
32
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females aged 18-65
  • Weight ≥ 50.0 kg
  • BMI 18.0 - 40.0 kg/m2
  • Able to participate, and willing to give written informed consent and to comply with the study restrictions
  • Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)

Exclusion Criteria:

  • Pregnant or lactating women and male partners of women who are pregnant or lactating
  • Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
  • QTcF > 450 msec for males and > 470 msec for females at Screening or Day -1
  • Donation or loss of blood over 350 mL within 60 days prior to screening
  • Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT02120547
Other Study ID Numbers  ICMJE TBR 652-1-121
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
Principal Investigator: Kenneth C Lasseter, MD Clinical Pharmacology of Miami, Inc.
PRS Account Tobira Therapeutics, Inc.
Verification Date August 2014

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