NCT04451083

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2020

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

June 21, 2020

Last Update Submit

April 7, 2024

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (16)

  • 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 Outcomes (7)

  • Cmax of FOY-251 [Pharmacokinetic]

    Up to 10 days

  • Tmax of FOY-251 [Pharmacokinetic]

    Up to 10 days

  • AUC of FOY-251 [Pharmacokinetic]

    Up to 10 days

  • AUC of FOY-251 [Pharmacokinetic]

    Up to 10 day

  • AUC of FOY-251 [Pharmacokinetic]

    Up to 10 days

  • +2 more secondary outcomes

Study Arms (1)

FOY-305

EXPERIMENTAL
Drug: FOY-305

Interventions

FOY-305DRUG

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

FOY-305

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Subjects with current or with a history of severe allergy to drugs or foods
  • Subjects with current or with a history of drug or alcohol abuse
  • Subjects with a history of hypersensitivity caused by ingredients of this drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukuoka Clinical Site 01

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Interventions

camostat

Study Officials

  • Susumu Nakade

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 30, 2020

Study Start

July 1, 2020

Primary Completion

August 17, 2020

Study Completion

August 17, 2020

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)