Healthy Adult Males
Conditions
Brief summary
To evaluate the safety of single and repeated administration of TAS3731.
Interventions
DRUGTAS3731 Dose1
Oral administration,1 day,QD
DRUGTAS3731 Dose2
Oral administration,7 days,QD
DRUGTAS3731 Dose3
Oral administration,7 days,BID
DRUGPlacebo
Oral administration, 1 day,QD
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Healthy adult male subjects who provided written informed consent to participate in the study 2. Aged 18 years or older and younger than 40 years at the time of informed consent 3. Body weight of 50 kg or more at screening: 4. Body mass index of 18.5 or more and less than 25.0 (Japanese) or less than 30.0 kg/m2 (Caucasian) 5. Capable of oral intake. Key
Exclusion criteria
1. Complications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease. The stomach or small intestine has been resected. 2. The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study. 3. Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded) 4. The patient has the following complications or a history of the following. 1. Had current or previous drug abuse (including use of illicit drugs) or alcoholism 2. Had current or previous hypersensitivity or allergy to drugs 5. Suspected COVID-19 disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and incidence rate of adverse events | Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16 |
| The number and incidence rate of adverse drug reactions | Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16 |
| Evaluation of Systolic and Diastolic blood pressure | Single dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 7 days, Repeated dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 16 days |
| Evaluation of pulse rate | Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days |
| Evaluation of body temperature | Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days |
| Number of participants with abnormal laboratory values | Single dose cohort：Change in number of participants with abnormal laboratory values between baseline and 7 days, Repeated dose cohort：Change in number of participants with abnormal laboratory values between baseline and 16 days |
| Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval | Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days |
| Evaluation of RR-interval | Single dose cohort：Change from Baseline Evaluation of RR-interval at 7 days, Repeated dose cohort：Change from Baseline Evaluation of RR-interval at 16 days |
Countries
Japan
Outcome results
None listed