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

Liver Insufficiency Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120547
• Other study ID #: TBR 652-1-121
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2014
• Last updated: August 19, 2014
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Tobira Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Diseases
• Liver Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami, Inc.	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tobira Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pro-inflammatory cytokines and biomarkers of bacterial translocation		28 days after receiving first dose of study drug	No
Primary	Multiple-dose pharmacokinetics of CVC	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.	0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14	No
Secondary	Safety and tolerability	Adverse events, concomitant medications, vital signs, 12-lead triplicate ECGs, clinical laboratory tests (chemistry, hematology, urinalysis) and physical examinations will be assessed.	Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects	Yes