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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: FOY-305

• Registration Number: NCT04451083
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Study Start: 2020-07-01
• Primary Completion: 2020-08-17
• Study Completion: 2020-08-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOY-305	FOY-305	-

Primary Outcome Measures

Name	Time	Method
Laboratory test [Safety and Tolerability]	Up to 10 days	Summary statistics of laboratory test (urinalysis)
Adverse events [Safety and Tolerability]	Up to 10 days	Number of participants with adverse events as assessed by CTCAE v5.0
Vital sign [Safety and Tolerability]	Up to 10 days	Summary statistics of SpO2
Body temperature [Safety and Tolerability]	Up to 10 days	Summary statistics of body temperature
Body weight [Safety and Tolerability]	Up to 10 days	Summary statistics of body weight
ECG parameter test [Safety and Tolerability]	Up to 10 days	Summary statistics of ECG parameter test (QTcF)

Secondary Outcome Measures

Name	Time	Method
Cmax of FOY-251 [Pharmacokinetic]	Up to 10 days	Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)
AUC of FOY-251 [Pharmacokinetic]	Up to 10 days	Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)
Tmax of FOY-251 [Pharmacokinetic]	Up to 10 days	Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)
T1/2 of FOY-251 [Pharmacokinetic]	Up to 10 days	Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)
CL/F of FOY-251 [Pharmacokinetic]	Up to 10 days	Assessment of the CL of FOY-251 (Active metabolite of FOY-305)

Trial Locations

Locations (1)

Fukuoka Clinical Site 01; 🇯🇵 Fukuoka, Japan