A Study of TAS3731 in Healthy Adults

NCT05691660 | Completed Phase 1

• 1 other identifier: 10074010
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Males

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

Single dose cohort

EXPERIMENTAL

Drug: TAS3731 Dose1; Drug: Placebo

Repeated dose cohort Once daily (QD)

EXPERIMENTAL

Drug: TAS3731 Dose2; Drug: Placebo

Repeated dose cohort Twice daily (BID)

EXPERIMENTAL

Drug: TAS3731 Dose3; Drug: Placebo

Interventions

TAS3731 Dose1 DRUG

Oral administration,1 day,QD

Single dose cohort

TAS3731 Dose2 DRUG

Oral administration,7 days,QD

Repeated dose cohort Once daily (QD)

TAS3731 Dose3 DRUG

Oral administration,7 days,BID

Repeated dose cohort Twice daily (BID)

Placebo DRUG

Oral administration, 1 day,QD

Single dose cohort

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male subjects who provided written informed consent to participate in the study
• Aged 18 years or older and younger than 40 years at the time of informed consent
• Body weight of 50 kg or more at screening:
• Body mass index of 18.5 or more and less than 25.0 (Japanese) or less than 30.0 kg/m2 (Caucasian)
• Capable of oral intake.

You may not qualify if:

• 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.
• Had current or previous drug abuse (including use of illicit drugs) or alcoholism
• Had current or previous hypersensitivity or allergy to drugs
• Suspected COVID-19 disease.

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

Study Officials

• Taiho Pharmaceutical Co., Ltd.

  Taiho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: January 20, 2023
• Study Start: January 17, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)