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OpenTrials
Completed

NCT Number: NCT02120547

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

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.

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Key information

Conditions

Liver Insufficiency Digestive System Diseases Hepatic Insufficiency Liver Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Inc.

Fort Lauderdale, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cenicriviroc in mild liver impaired

Drug

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 names: CVC

Cenicriviroc in moderate liver impaired

Drug

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 names: CVC

Primary outcomes

  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 outcomes

  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 outcomes

  1. Pro-inflammatory cytokines and biomarkers of bacterial translocation

    Time frame: 28 days after receiving first dose of study drug

Sponsors and collaborators

Lead sponsor

Tobira Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2014
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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