A Study of TAS3731 in Healthy Adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Males
• Intervention / Treatment: Drug: TAS3731 Dose1; Drug: Placebo; Drug: Placebo; Drug: Placebo; Drug: TAS3731 Dose2; Drug: TAS3731 Dose3

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • A site selected by Taiho Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose cohort	Drug: TAS3731 Dose1; Oral administration,1 day,QD; Drug: Placebo; Oral administration, 1 day,QD; Drug: Placebo; Oral administration, 7 days,QD; Drug: Placebo; Oral administration, 7 days,BID
Experimental: Repeated dose cohort Once daily (QD)	Drug: Placebo; Oral administration, 1 day,QD; Drug: Placebo; Oral administration, 7 days,QD; Drug: Placebo; Oral administration, 7 days,BID; Drug: TAS3731 Dose2; Oral administration,7 days,QD
Experimental: Repeated dose cohort Twice daily (BID)	Drug: Placebo; Oral administration, 1 day,QD; Drug: Placebo; Oral administration, 7 days,QD; Drug: Placebo; Oral administration, 7 days,BID; Drug: TAS3731 Dose3; Oral administration,7 days,BID

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taiho Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): May 21, 2024
• Study Completion (Actual): May 21, 2024

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 10074010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No