Healthy Subjects Clinical Trial
Official title:
A Phase 1, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of FG 4592 on the Pharmacokinetics of Warfarin in Healthy Subjects
This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin alone and in combination with multiple doses of FG-4592, and will evaluate the effect of multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.
The study consists of 2 periods, separated by a washout period (a minimum of 14 days after
warfarin dosing on Day 1, Period 1). Screening takes place from Day -22 to Day -2.
Subjects are admitted to the clinical unit on Day -1 of Period 1. On Day 1 of the first
period, subjects receive a single oral dose of warfarin. After completion of all assessments
on Day 8, subjects are discharged from the clinical unit on the condition that there are no
medical reasons for a prolonged stay. They return to the clinical unit on Day -1 of the
second period, after the washout period.
In Period 2, the subjects receive multiple doses of FG 4592. On Day 7 of Period 2, FG 4592
is given concomitantly with warfarin. After completion of all assessments on Day 16 of
Period 2, subjects are discharged from the clinic on the condition that there are no medical
reasons for a prolonged stay. The subjects return for an End of Study Visit (ESV) 5 to 9
days after the last assessment of Period 2 (or after early withdrawal).
Safety assessments are performed throughout the study. Blood and urine samples are collected
for PK and PD assessments.
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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