Back to resultsClinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
Primary Purpose
Hepatic Insufficiency, Healthy
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
FYU-981
Sponsored by
About this trial
This is an interventional basic science trial for Hepatic Insufficiency
Eligibility 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)
Sites / Locations
- Mochida Investigational sites
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Normal group
Mild hepatic-insufficient group
Moderate hepatic-insufficient group
Severe hepatic-insufficient group
Arm Description
Healthy control subjects
Patients with mild hepatic impaired function (Child-Pugh A)
Patients with moderate hepatic impaired function (Child-Pugh B)
Patients with severe hepatic impaired function (Child-Pugh C)
Outcomes
Primary Outcome Measures
Pharmacokinetics (Cmax: Maximum plasma concentration)
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Pharmacokinetics (kel: Elimination rate constant)
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Pharmacokinetics (MRT: Mean residence time)
Pharmacodynamics (Serum concentration of uric acid)
Pharmacodynamics (Amount of uric acid excreted in urine)
Safety (Incidence of treatment-emergent adverse events)
Secondary Outcome Measures
Full Information
NCT ID
NCT03306667
First Posted
September 20, 2017
Last Updated
September 21, 2018
Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03306667
Brief Title
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
Official Title
Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal group
Arm Type
Experimental
Arm Description
Healthy control subjects
Arm Title
Mild hepatic-insufficient group
Arm Type
Experimental
Arm Description
Patients with mild hepatic impaired function (Child-Pugh A)
Arm Title
Moderate hepatic-insufficient group
Arm Type
Experimental
Arm Description
Patients with moderate hepatic impaired function (Child-Pugh B)
Arm Title
Severe hepatic-insufficient group
Arm Type
Experimental
Arm Description
Patients with severe hepatic impaired function (Child-Pugh C)
Intervention Type
Drug
Intervention Name(s)
FYU-981
Intervention Description
Oral single dosing
Primary Outcome Measure Information:
Title
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame
48 hours
Title
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame
48 hours
Title
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame
48 hours
Title
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame
48 hours
Title
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame
48 hours
Title
Pharmacokinetics (kel: Elimination rate constant)
Time Frame
48 hours
Title
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time Frame
48 hours
Title
Pharmacokinetics (MRT: Mean residence time)
Time Frame
48 hours
Title
Pharmacodynamics (Serum concentration of uric acid)
Time Frame
48 hours
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
48 hours
Title
Safety (Incidence of treatment-emergent adverse events)
Time Frame
192 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeki Matsumoto
Organizational Affiliation
Clinical Research Department
Official's Role
Study Director
Facility Information:
Facility Name
Mochida Investigational sites
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
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