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

Fuji Yakuhin

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Insufficiency

Treatments: Drug: FYU-981, (Oral single dosing)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02347046

FYU-981-005

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Moderately-decreased group

Experimental group

Description:

(eGFR: \>=30mL/min/1.73m\^2 and \< 60mL/min/1.73m\^2)

Treatment:

Drug: FYU-981, (Oral single dosing)

Slightly-decreased group

Experimental group

Description:

(eGFR: \>=60mL/min/1.73m\^2 and \< 90mL/min/1.73m\^2)

Treatment:

Drug: FYU-981, (Oral single dosing)

Normal group

Experimental group

Description:

(eGFR: \>=90mL/min/1.73m\^2)

Treatment:

Drug: FYU-981, (Oral single dosing)