Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 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.

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.

Condition or disease Intervention/treatment Phase
Liver Insufficiency Drug: Cenicriviroc in mild liver impaired Drug: Cenicriviroc in moderate liver impaired Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Pro-inflammatory cytokines and biomarkers of bacterial translocation [ Time Frame: 28 days after receiving first dose of study drug ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02120547


Locations
Layout table for location information
United States, Florida
Clinical Pharmacology of Miami, Inc.
Fort Lauderdale, Florida, United States, 33014
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Kenneth C Lasseter, MD Clinical Pharmacology of Miami, Inc.
Layout table for additonal information
Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02120547    
Other Study ID Numbers: TBR 652-1-121
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014
Keywords provided by Tobira Therapeutics, Inc.:
Liver Insufficiency
Hepatic impairment
Additional relevant MeSH terms:
Layout table for MeSH terms
Cenicriviroc
Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents