Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-08-17

Brief Summary

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To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOY-305

Group Type EXPERIMENTAL

FOY-305

Intervention Type DRUG

Multiple-dose of FOY-305 will be administered orally at 4 times/day.

Interventions

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FOY-305

Multiple-dose of FOY-305 will be administered orally at 4 times/day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Japanese healthy adult male subjects
2. Age (at the time of informed consent): ≥18 yeas, ≤ 45 yeas
3. BMI (at the time of screening test): ≥18.5 kg/m2, \<25.0 kg/m2

Exclusion Criteria

1. Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
2. Subjects with current or with a history of severe allergy to drugs or foods
3. Subjects with current or with a history of drug or alcohol abuse
4. Subjects with a history of hypersensitivity caused by ingredients of this drug

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes