A Study of TAS3731 in Healthy Adults

Phase 1

Completed

• Conditions: Healthy Adult Males
• Interventions: Drug: TAS3731 Dose1; Drug: TAS3731 Dose2; Drug: TAS3731 Dose3; Drug: Placebo

• Registration Number: NCT05691660
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the safety of single and repeated administration of TAS3731.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-24
• Study Start: 2023-01-17
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-20
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 238

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeated dose cohort Twice daily (BID)	Placebo	-
Single dose cohort	TAS3731 Dose1	-
Single dose cohort	Placebo	-
Repeated dose cohort Once daily (QD)	TAS3731 Dose2	-
Repeated dose cohort Once daily (QD)	Placebo	-
Repeated dose cohort Twice daily (BID)	TAS3731 Dose3	-

Primary Outcome Measures

Name	Time	Method
The number and incidence rate of adverse events	Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
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
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
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

Trial Locations

Locations (1)

A site selected by Taiho Pharmaceutical Co., Ltd.; 🇯🇵 Tokyo, Japan