Healthy Subjects Clinical Trial
Official title:
A Phase 1, Double-blind, Randomized, Placebo-controlled, 4-way Crossover Study to Evaluate the Dose-proportionality and Pharmacokinetics of FG-4592 in Healthy Young and Elderly Male and Female Subjects
This study evaluates the concentration of FG-4592 in the blood over a certain period after
the intake of different doses, and assesses the effects, the safety and the tolerability of
the study drug in healthy young and elderly male and female subjects.
On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a
placebo, depending on the treatment sequence to which they are randomized. For each period
the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all
assessments are completed on Day 4 of each period, and return for an End of Study visit
(ESV) between 5 and 9 days after the last assessment of Period 4.
In this study eligible subjects reside in the clinic for 4 periods of 6 days (Day -2 through
Day 4). Screening takes place from Day -23 through Day -3. Subjects are admitted to the
clinic on Day -2 of Period 1. Within each cohort (young and elderly subjects), subjects are
randomized to one of 24 treatment sequences of 4 treatment options (3 different doses of
FG-4592 and placebo) and 4 periods.
On Day 1 of each period, subjects receive a single oral dose of FG-4592 or placebo followed
by a 72-hour evaluation period. Subjects are discharged on Day 4, if there are no medical
reasons for a prolonged stay. Each period is separated by a wash-out period of at least 10
days between dosing on Day 1 of the previous period and dosing on Day 1 of the following
period. The subjects return for an end-of-study visit (ESV) 5-9 days after the last
assessment of Period 4 (or after early withdrawal).
Plasma and urine samples are collected for pharmacokinetic (PK) and pharmacodynamic (PD)
assessments. Safety assessments are performed throughout the study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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