Clinical trial NCT05691660: A Study of TAS3731 in Healthy Adults
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Males
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 238
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of single and repeated administration of TAS3731.


Eligibility 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.

Primary outcomes:
measure: The number and incidence rate of adverse events
timeFrame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
measure: The number and incidence rate of adverse drug reactions
timeFrame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
measure: Evaluation of Systolic and Diastolic blood pressure
timeFrame: 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
measure: Evaluation of pulse rate
timeFrame: Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days
measure: Evaluation of body temperature
timeFrame: Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days
measure: Number of participants with abnormal laboratory values
timeFrame: 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
measure: Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval
timeFrame: Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days
measure: Evaluation of RR-interval
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References: