Status:
COMPLETED
A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborating Sponsors:
FibroGen
Conditions:
Pharmacokinetics of FG-4592
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 combi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control.
- Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
- Female subject must be either of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test at screening and Day -1 and must use two forms of birth control.
- Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration.
Exclusion
- Subject has a known or suspected hypersensitivity to FG 4592, warfarin, or any components of the formulations used.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit \[Day -1\].
- Subject is lactose intolerant.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02252731
Start Date
September 1 2013
End Date
November 1 2013
Last Update
September 30 2014
Active Locations (1)
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1
Parexel International GmbH
Berlin, Germany, 14050