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

Phase 1

Completed

• Conditions: Healthy; Renal Insufficiency
• Interventions: Drug: FYU-981, (Oral single dosing)

• Registration Number: NCT02347046
• Lead Sponsor: Fuji Yakuhin Co., 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 renal insufficiency and with normal renal function.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-27
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderately-decreased group	FYU-981, (Oral single dosing)	(eGFR: \>=30mL/min/1.73m\^2 and \< 60mL/min/1.73m\^2)
Slightly-decreased group	FYU-981, (Oral single dosing)	(eGFR: \>=60mL/min/1.73m\^2 and \< 90mL/min/1.73m\^2)
Normal group	FYU-981, (Oral single dosing)	(eGFR: \>=90mL/min/1.73m\^2)

Primary Outcome Measures

Name	Time	Method
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
Pharmacokinetics (MRT: Mean residence time)	48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)	48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)	48 hours

Trial Locations

Locations (1)

Japan; 🇯🇵 Kagoshima, Japan