Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects
NCT05391724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2022-05-26
Summary
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.
Conditions
- Hepatic Impairment
Interventions
- DRUG
-
CMX001
single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2011-09-30
- Completion
- 2011-09-30
Countries
- United States
Study Locations
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