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

• Sponsor: Mochida Pharmaceutical Company, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03306667
• Collaborator: Fuji Yakuhin Co., Ltd. (Industry)
• Enrollment: 24
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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 function.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency; Healthy	Drug: FYU-981	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency
• Actual Study Start Date: Oct 6, 2017
• Actual Primary Completion Date: Jun 20, 2018
• Actual Study Completion Date: Jun 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal group Healthy control subjects	Drug: FYU-981; Oral single dosing
Experimental: Mild hepatic-insufficient group Patients with mild hepatic impaired function (Child-Pugh A)	Drug: FYU-981; Oral single dosing
Experimental: Moderate hepatic-insufficient group Patients with moderate hepatic impaired function (Child-Pugh B)	Drug: FYU-981; Oral single dosing
Experimental: Severe hepatic-insufficient group Patients with severe hepatic impaired function (Child-Pugh C)	Drug: FYU-981; Oral single dosing

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (Cmax: Maximum plasma concentration) [48 hours]

2. Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) [48 hours]

3. Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) [48 hours]

4. Pharmacokinetics (AUC: Area under the plasma concentration-time curve) [48 hours]

5. Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) [48 hours]

6. Pharmacokinetics (kel: Elimination rate constant) [48 hours]

7. Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) [48 hours]

8. Pharmacokinetics (MRT: Mean residence time) [48 hours]

9. Pharmacodynamics (Serum concentration of uric acid) [48 hours]

10. Pharmacodynamics (Amount of uric acid excreted in urine) [48 hours]

11. Safety (Incidence of treatment-emergent adverse events) [192 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mochida Investigational sites	Tokyo		Japan

Sponsors and Collaborators

• Mochida Pharmaceutical Company, Ltd.
• Fuji Yakuhin Co., Ltd.

Investigators

• Study Director: Shigeki Matsumoto, Clinical Research Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mochida Pharmaceutical Company, Ltd.
• ClinicalTrials.gov Identifier: NCT03306667
• Other Study ID Numbers: FYU-981-015
• First Posted: Oct 11, 2017
• Last Update Posted: Sep 24, 2018
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure; Dotinurad

Study Results

No Results Posted as of Sep 24, 2018