Clinical Pharmacology of FYU-981 (Elder Subjects)

Fuji Yakuhin

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02344875

FYU-981-004

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.

Enrollment: 24 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese adult subjects
• 20-35 Years (non-elder groups)
• 65- Years (elder groups)
• Body mass index: >=18.5 and <25.0

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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24 participants in 4 patient groups

Male elder subjects

Experimental group

Description:

Male 65- Years

Treatment:

Drug: FYU-981, (Oral single dosing)

Male non-elder subjects

Experimental group

Description:

Male 20-35 Years

Treatment:

Drug: FYU-981, (Oral single dosing)

Female elder subjects

Experimental group

Description:

Female 65- Years

Treatment:

Drug: FYU-981, (Oral single dosing)

Female non-elder subjects

Experimental group

Description:

Female 20-35 Years

Treatment:

Drug: FYU-981, (Oral single dosing)