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

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ClinicalTrials.gov Identifier: NCT03306667
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
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)
Estimated 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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : October 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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 ClinicalTrials.gov identifier (NCT number): NCT03306667


Contacts
Contact: Shigeki Matsumoto +81-3-3225-6331 smatsumo@mochida.co.jp

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

Responsible Party: Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier: NCT03306667     History of Changes
Other Study ID Numbers: FYU-981-015
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

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 Diseases
Digestive System Diseases