A Study of TAS3731 in Healthy Adults

Healthy Adult Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691660
• Other study ID #: 10074010
• Status: Recruiting
• Phase: Phase 1
• Start date: January 17, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: Ken Tsukamoto
• Phone: +81-3-3293-2455
• Email: k-tsukamoto[@]taiho.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Males

Intervention

Drug:
• TAS3731 Dose1
Oral administration,1 day,QD
• TAS3731 Dose2
Oral administration,7 days,QD
• TAS3731 Dose3
Oral administration,7 days,BID
• Placebo
Oral administration, 1 day,QD
• Placebo
Oral administration, 7 days,QD
• Placebo
Oral administration, 7 days,BID

Locations

Country	Name	City	State
Japan	A site selected by Taiho Pharmaceutical Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and incidence rate of adverse events		Single dose cohort:Day 1 to 7, Repeated dose cohort:Day 1 to 16
Primary	The number and incidence rate of adverse drug reactions		Single dose cohort:Day 1 to 7, Repeated dose cohort:Day 1 to 16
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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