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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451083
• Other study ID #: FOY-305-02
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: August 17, 2020

Study information

• Verified date: April 2024
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Japan	Fukuoka Clinical Site 01	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events [Safety and Tolerability]	Number of participants with adverse events as assessed by CTCAE v5.0	Up to 10 days
Primary	Vital sign [Safety and Tolerability]	Summary statistics of blood pressure	Up to 10 days
Primary	Vital sign [Safety and Tolerability]	Summary statistics of pulse rate	Up to 10 days
Primary	Vital sign [Safety and Tolerability]	Summary statistics of SpO2	Up to 10 days
Primary	Body temperature [Safety and Tolerability]	Summary statistics of body temperature	Up to 10 days
Primary	Body weight [Safety and Tolerability]	Summary statistics of body weight	Up to 10 days
Primary	ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (Heart Rate)	Up to 10 days
Primary	ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (RR)	Up to 10 days
Primary	ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (PR)	Up to 10 days
Primary	ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (QRS)	Up to 10 days
Primary	ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (QT)	Up to 10 days
Primary	ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (QTcF)	Up to 10 days
Primary	Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (hematologic test)	Up to 10 days
Primary	Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (blood biochemistry test)	Up to 10 days
Primary	Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (blood coagulation test)	Up to 10 days
Primary	Laboratory test [Safety and Tolerability]	Summary statistics of laboratory test (urinalysis)	Up to 10 days
Secondary	Cmax of FOY-251 [Pharmacokinetic]	Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
Secondary	Tmax of FOY-251 [Pharmacokinetic]	Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
Secondary	AUC of FOY-251 [Pharmacokinetic]	Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
Secondary	AUC of FOY-251 [Pharmacokinetic]	Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)	Up to 10 day
Secondary	AUC of FOY-251 [Pharmacokinetic]	Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
Secondary	T1/2 of FOY-251 [Pharmacokinetic]	Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)	Up to 10 days
Secondary	CL/F of FOY-251 [Pharmacokinetic]	Assessment of the CL of FOY-251 (Active metabolite of FOY-305)	Up to 10 days