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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03306667
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : September 24, 2018
Fuji Yakuhin Co., Ltd.
Information provided by (Responsible Party):
Mochida Pharmaceutical Company, Ltd.

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 Type : Interventional  (Clinical Trial)
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 : October 6, 2017
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 25, 2018

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

Primary Outcome Measures :
  1. Pharmacokinetics (Cmax: Maximum plasma concentration) [ Time Frame: 48 hours ]
  2. Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) [ Time Frame: 48 hours ]
  3. Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) [ Time Frame: 48 hours ]
  4. Pharmacokinetics (AUC: Area under the plasma concentration-time curve) [ Time Frame: 48 hours ]
  5. Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) [ Time Frame: 48 hours ]
  6. Pharmacokinetics (kel: Elimination rate constant) [ Time Frame: 48 hours ]
  7. Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) [ Time Frame: 48 hours ]
  8. Pharmacokinetics (MRT: Mean residence time) [ Time Frame: 48 hours ]
  9. Pharmacodynamics (Serum concentration of uric acid) [ Time Frame: 48 hours ]
  10. Pharmacodynamics (Amount of uric acid excreted in urine) [ Time Frame: 48 hours ]
  11. Safety (Incidence of treatment-emergent adverse events) [ Time Frame: 192 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03306667

Mochida Investigational sites
Tokyo, Japan
Sponsors and Collaborators
Mochida Pharmaceutical Company, Ltd.
Fuji Yakuhin Co., Ltd.
Study Director: Shigeki Matsumoto Clinical Research Department

Responsible Party: Mochida Pharmaceutical Company, Ltd. Identifier: NCT03306667     History of Changes
Other Study ID Numbers: FYU-981-015
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 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
Liver Diseases
Digestive System Diseases