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

Healthy Clinical Trial

Official title:

Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306667
• Other study ID #: FYU-981-015
• Status: Completed
• Phase: Phase 1
• Start date: October 6, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: September 2018
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 25, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Hepatic Insufficiency

Intervention

Drug:
• FYU-981
Oral single dosing

Locations

Country	Name	City	State
Japan	Mochida Investigational sites	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.	Fuji Yakuhin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (Cmax: Maximum plasma concentration)		48 hours
Primary	Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)		48 hours
Primary	Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)		48 hours
Primary	Pharmacokinetics (AUC: Area under the plasma concentration-time curve)		48 hours
Primary	Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)		48 hours
Primary	Pharmacokinetics (kel: Elimination rate constant)		48 hours
Primary	Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)		48 hours
Primary	Pharmacokinetics (MRT: Mean residence time)		48 hours
Primary	Pharmacodynamics (Serum concentration of uric acid)		48 hours
Primary	Pharmacodynamics (Amount of uric acid excreted in urine)		48 hours
Primary	Safety (Incidence of treatment-emergent adverse events)		192 hours