Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

• Status: Completed
• Trial end date: 2018-06-25
• Target enrollment: 0
• Participant gender: All

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 function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.
• Collaborator: Fuji Yakuhin Co., Ltd.
• Treatments: Dotinurad

Criteria

Inclusion Criteria:

• Adult healthy subjects or adult cirrhosis patients

• Body mass index: >=18.5 and <30.0

Exclusion Criteria:

• 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)