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Completed

NCT Number: NCT05691660

A Study of TAS3731 in Healthy Adults

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

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Key information

Conditions

Healthy Adult Males

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

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.
  • 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.

Treatment and study plan

TAS3731 Dose1

Drug

Oral administration,1 day,QD

TAS3731 Dose2

Drug

Oral administration,7 days,QD

TAS3731 Dose3

Drug

Oral administration,7 days,BID

Placebo

Drug

Oral administration, 1 day,QD

Primary outcomes

  1. The number and incidence rate of adverse events

    Time frame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16

  2. The number and incidence rate of adverse drug reactions

    Time frame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16

  3. Evaluation of Systolic and Diastolic blood pressure

    Time frame: 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

  4. Evaluation of pulse rate

    Time frame: Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days

  5. Evaluation of body temperature

    Time frame: Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days

  6. Number of participants with abnormal laboratory values

    Time frame: 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

  7. Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval

    Time frame: Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days

  8. Evaluation of RR-interval

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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