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

Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04451083
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
1.5
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Aug 17, 2020
Actual Study Completion Date :
Aug 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: FOY-305

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

Outcome Measures

Primary Outcome Measures

  1. Adverse events [Safety and Tolerability] [Up to 10 days]

    Number of participants with adverse events as assessed by CTCAE v5.0

  2. Vital sign [Safety and Tolerability] [Up to 10 days]

    Summary statistics of blood pressure

  3. Vital sign [Safety and Tolerability] [Up to 10 days]

    Summary statistics of pulse rate

  4. Vital sign [Safety and Tolerability] [Up to 10 days]

    Summary statistics of SpO2

  5. Body temperature [Safety and Tolerability] [Up to 10 days]

    Summary statistics of body temperature

  6. Body weight [Safety and Tolerability] [Up to 10 days]

    Summary statistics of body weight

  7. ECG parameter test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of ECG parameter test (Heart Rate)

  8. ECG parameter test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of ECG parameter test (RR)

  9. ECG parameter test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of ECG parameter test (PR)

  10. ECG parameter test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of ECG parameter test (QRS)

  11. ECG parameter test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of ECG parameter test (QT)

  12. ECG parameter test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of ECG parameter test (QTcF)

  13. Laboratory test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of laboratory test (hematologic test)

  14. Laboratory test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of laboratory test (blood biochemistry test)

  15. Laboratory test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of laboratory test (blood coagulation test)

  16. Laboratory test [Safety and Tolerability] [Up to 10 days]

    Summary statistics of laboratory test (urinalysis)

Secondary Outcome Measures

  1. Cmax of FOY-251 [Pharmacokinetic] [Up to 10 days]

    Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)

  2. Tmax of FOY-251 [Pharmacokinetic] [Up to 10 days]

    Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)

  3. AUC of FOY-251 [Pharmacokinetic] [Up to 10 days]

    Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)

  4. AUC of FOY-251 [Pharmacokinetic] [Up to 10 day]

    Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)

  5. AUC of FOY-251 [Pharmacokinetic] [Up to 10 days]

    Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)

  6. T1/2 of FOY-251 [Pharmacokinetic] [Up to 10 days]

    Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)

  7. CL/F of FOY-251 [Pharmacokinetic] [Up to 10 days]

    Assessment of the CL of FOY-251 (Active metabolite of FOY-305)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fukuoka Clinical Site 01 Fukuoka Japan 812-0025

Sponsors and Collaborators

  • Ono Pharmaceutical Co. Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT04451083
Other Study ID Numbers:
  • FOY-305-02
First Posted:
Jun 30, 2020
Last Update Posted:
Jun 16, 2021
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Camostat

Study Results

No Results Posted as of Jun 16, 2021