Mass Balance Study of FYU-981

Fuji Yakuhin

Status and phase: Completed; Phase 2

Conditions: Healthy Male Subjects

Treatments: Drug: 14C-FYU-981

Study type: Interventional

Funder types: Industry

Identifiers

NCT02901366

FYU-981-009

Details and patient eligibility

About

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.

Enrollment: 6 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese healthy adult subjects
• 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
• Have participated in a [14C]-study within the last 12 months prior to dosing of the investigational drug
• Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
• Occupationally exposed worker

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

14C-FYU-981

Experimental group

Description:

14C-FYU-981, (Oral single dosing)

Treatment:

Drug: 14C-FYU-981