Clinical Pharmacology of FYU-981 (Final Formulation)

Mochida Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FYU-981

Study type: Interventional

Funder types: Industry

Identifiers

NCT03350373

FYU-981-016

Details and patient eligibility

About

This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.

Enrollment: 12 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Fasted dosing followed by fed dosing

Experimental group

Description:

Dosing of FYU-981 in the fasted state followed by fed dosing

Treatment:

Drug: FYU-981

Fed dosing followed by fasted dosing

Experimental group

Description:

Dosing of FYU-981 in the fed state followed by fasted dosing

Treatment:

Drug: FYU-981