Hepatic Impairment Clinical Trial
Official title:
An Open-Label Study to Determine the Safety and Pharmacokinetics of CMX001 in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted subjects with moderate and severe hepatic impairment.
A maximum of 24 subjects will be studied at multiple sites in the Unites States. Eight subjects with normal hepatic function and 8 subjects with moderate hepatic impairment will be enrolled on Cohort 1 and an additional 8 subjects with severe hepatic impairment may be enrolled in Cohort 2. The severity of hepatic impairment will be assessed according to the Child-Pugh-Turcotte (CPT) score1 (see Table 4-2). Because CMX001 is highly protein-bound, to avoid confounding the PK assessment of hepatic impairment versus hypoalbuminemia, only patients with serum albumin levels >3 g/dL will be enrolled in this study. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Check-in. Subjects who have met inclusion and exclusion criteria will check in to the clinic on Day -1 and receive a single oral dose of CMX001 (2 mg/kg of ideal body weight rounded to the closest 20 mg) on Day 1. The study design schematic is presented in Table 4-3. Subjects will be discharged from the clinic on Day 2 (if stable in the opinion of the Investigator), return for outpatient visits on Days 3 through 6 for safety assessments and PK sampling, and return for an End of Study Visit on Day 14 ± 2 for safety assessments. Subjects may be confined to the clinic during the period of Day -1 to Day 6 at the discretion of the Investigator, after discussion with the Medical Monitor. ;
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