Repeated Dose Phase I Study of FYU-981

Fuji Yakuhin

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo, (Oral daily dosing for 7 days); Drug: FYU-981, (Oral daily dosing for 7 days)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02348333

FYU-981-002

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.

Enrollment: 18 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: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

FYU-981

Active Comparator group

Treatment:

Drug: FYU-981, (Oral daily dosing for 7 days)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo, (Oral daily dosing for 7 days)