Status:
COMPLETED
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
Lead Sponsor:
Mochida Pharmaceutical Company, Ltd.
Collaborating Sponsors:
Fuji Yakuhin Co., Ltd.
Conditions:
Hepatic Insufficiency
Healthy
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic func...
Eligibility Criteria
Inclusion
- Adult healthy subjects or adult cirrhosis patients
- Body mass index: \>=18.5 and \<30.0
Exclusion
- Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03306667
Start Date
October 6 2017
End Date
June 25 2018
Last Update
September 24 2018
Active Locations (1)
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1
Mochida Investigational sites
Tokyo, Japan