Healthy, Hepatic Insufficiency
Conditions
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.
Interventions
DRUGFYU-981
Oral single dosing
Sponsors
Fuji Yakuhin Co., Ltd.
Mochida Pharmaceutical Company, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (MRT: Mean residence time) | 48 hours |
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 48 hours |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 48 hours |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 48 hours |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 48 hours |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 48 hours |
| Pharmacokinetics (kel: Elimination rate constant) | 48 hours |
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) | 48 hours |
| Pharmacodynamics (Serum concentration of uric acid) | 48 hours |
| Pharmacodynamics (Amount of uric acid excreted in urine) | 48 hours |
| Safety (Incidence of treatment-emergent adverse events) | 192 hours |
Countries
Japan
Outcome results
None listed