Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Fuji Yakuhin Co., Ltd.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (Cmax: Maximum plasma concentration)
Study Overview
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 renal insufficiency and with normal renal function.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Japanese adult subjects
- •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
Arms & Interventions
Moderately-decreased group
(eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2)
Intervention: FYU-981, (Oral single dosing) (Drug)
Slightly-decreased group
(eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2)
Intervention: FYU-981, (Oral single dosing) (Drug)
Normal group
(eGFR: >=90mL/min/1.73m^2)
Intervention: FYU-981, (Oral single dosing) (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time Frame: 48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time Frame: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Time Frame: 48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time Frame: 48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported