Fukuoka Clinical Site 01
Fukuoka, 812-0025, Japan
Completed
NCT Number: NCT04451083
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
FOY-305
DrugMultiple-dose of FOY-305 will be administered orally at 4 times/day.
Primary outcomes
-
Adverse events [Safety and Tolerability]
Time frame: Up to 10 days
Number of participants with adverse events as assessed by CTCAE v5.0
-
Vital sign [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of blood pressure
-
Vital sign [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of pulse rate
-
Vital sign [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of SpO2
-
Body temperature [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of body temperature
-
Body weight [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of body weight
-
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (Heart Rate)
-
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (RR)
-
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (PR)
-
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (QRS)
-
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (QT)
-
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (QTcF)
-
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (hematologic test)
-
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (blood biochemistry test)
-
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (blood coagulation test)
-
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (urinalysis)
Secondary outcomes
-
Cmax of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)
-
Tmax of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)
-
AUC of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)
-
AUC of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 day
Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)
-
AUC of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)
-
T1/2 of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)
-
CL/F of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
Assessment of the CL of FOY-251 (Active metabolite of FOY-305)
Sponsors and collaborators
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Industry
Registry information
Important dates
- Study start
- 2020
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Jun 30, 2020
- Registry last updated
- Apr 9, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial Details
Completed
The Primary Purpose of This Study is to Determine if Biotin, Vitamin B7 is an Effective Way to Label Platelets in Survival and Recovery Studies.
NCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial Details
Completed
A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers
NCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial Details
Completed
Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
NCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details