A Study of TAS3731 in Healthy Adults

Taiho Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Males

Treatments: Drug: TAS3731 Dose3; Drug: TAS3731 Dose1; Drug: Placebo; Drug: TAS3731 Dose2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05691660

10074010

Details and patient eligibility

About

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

Enrollment: 238 patients

Sex: Male

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

238 participants in 3 patient groups

Single dose cohort

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: TAS3731 Dose1

Repeated dose cohort Once daily (QD)

Experimental group

Treatment:

Drug: TAS3731 Dose2

Drug: Placebo

Drug: Placebo

Drug: Placebo

Repeated dose cohort Twice daily (BID)

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: TAS3731 Dose3