Healthy Subjects Clinical Trial
Official title:
A Phase 1, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of FG-4592 in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects. The results are compared to the data gained from subjects with normal liver function.
The effect of moderate hepatic impairment on the pharmacokinetics (PK), safety and
tolerability of a single dose of FG-4592 in male and female subjects is investigated. Data
obtained from these subjects are compared to data from BMI-, age- and sex-matched subjects
with normal hepatic function. Both groups consist of 8 subjects.
Screening takes place from Days -22 to -2 before admission to the clinical unit on Day -1.
Administration of the trial medication takes place on Day 1 under fasted conditions. Healthy
subjects are discharged on Day 5 and subjects with moderate hepatic impairment on Day 7, if
there is no reason to extend the stay. An end-of-study visit (ESV) takes place 5 to 9 days
after (early) discharge.
Safety assessments are performed throughout the study.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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