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To evaluate the safety of single and repeated administration of TAS3731.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose cohort | Experimental |
| |
| Repeated dose cohort Once daily (QD) | Experimental |
| |
| Repeated dose cohort Twice daily (BID) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS3731 Dose1 | Drug | Oral administration,1 day,QD |
| |
| Measure | Description | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria
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.
The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.
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)
The patient has the following complications or a history of the following.
Suspected COVID-19 disease.
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| Name | Affiliation | Role |
|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Taiho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A site selected by Taiho Pharmaceutical Co., Ltd. | Tokyo | Japan |
Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical\_trial\_information\_disclosure\_policy/index.html.
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| TAS3731 Dose2 |
| Drug |
Oral administration,7 days,QD |
|
| TAS3731 Dose3 | Drug | Oral administration,7 days,BID |
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| Placebo | Drug | Oral administration, 1 day,QD |
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| Placebo | Drug | Oral administration, 7 days,QD |
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| Placebo | Drug | Oral administration, 7 days,BID |
|