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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: FOY-305

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Fukuoka Clinical Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FOY-305	Drug: FOY-305; Multiple-dose of FOY-305 will be administered orally at 4 times/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events [Safety and Tolerability]	Number of participants with adverse events as assessed by CTCAE v5.0	Up to 10 days
Vital sign [Safety and Tolerability]	Summary statistics of blood pressure	Up to 10 days
Vital sign [Safety and Tolerability]	Summary statistics of pulse rate	Up to 10 days
Vital sign [Safety and Tolerability]	Summary statistics of SpO2	Up to 10 days
Body temperature [Safety and Tolerability]	Summary statistics of body temperature	Up to 10 days
Body weight [Safety and Tolerability]	Summary statistics of body weight	Up to 10 days
ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (Heart Rate)	Up to 10 days
ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (RR)	Up to 10 days
ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (PR)	Up to 10 days
ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (QRS)	Up to 10 days
ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (QT)	Up to 10 days
ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (QTcF)	Up to 10 days
Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (hematologic test)	Up to 10 days
Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (blood biochemistry test)	Up to 10 days
Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (blood coagulation test)	Up to 10 days
Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (urinalysis)	Up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of FOY-251 [Pharmacokinetic]	Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
Tmax of FOY-251 [Pharmacokinetic]	Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
AUC of FOY-251 [Pharmacokinetic]	Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
AUC of FOY-251 [Pharmacokinetic]	Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)	Up to 10 day
AUC of FOY-251 [Pharmacokinetic]	Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
T1/2 of FOY-251 [Pharmacokinetic]	Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
CL/F of FOY-251 [Pharmacokinetic]	Assessment of the CL of FOY-251 (Active metabolite of FOY-305)	Up to 10 days

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Susumu Nakade, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): August 17, 2020
• Study Completion (Actual): August 17, 2020

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Camostat
• Other Study ID Numbers: FOY-305-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: https://www.ono.co.jp/eng/rd/policy.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No