A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)

NCT ID: NCT04979572

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2022-01-26

Brief Summary

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects

Conditions

Healthy Adult Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg

Single dose of TS-172 or placebo before breakfast

Group Type: EXPERIMENTAL

TS-172

Intervention Type: DRUG

• Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting)
• Multiple dose of TS-172 90 mg before breakfast and dinner

Placebo

Intervention Type: DRUG

• Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2)
• Multiple dose of TS-172 placebo before breakfast and dinner

Part B (multiple dose) : Step 5: TS-172 90 mg

Multiple dose of TS-172 or placebo before breakfast and dinner

Group Type: EXPERIMENTAL

TS-172

Intervention Type: DRUG

• Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting)
• Multiple dose of TS-172 90 mg before breakfast and dinner

Placebo

Intervention Type: DRUG

• Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2)
• Multiple dose of TS-172 placebo before breakfast and dinner

Interventions

TS-172

• Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting)
• Multiple dose of TS-172 90 mg before breakfast and dinner

Intervention Type: DRUG

Placebo

• Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2)
• Multiple dose of TS-172 placebo before breakfast and dinner

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent

2. Those with a BMI of 18.5 or more and less than 25.0 at screening test

3. Those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.

Exclusion Criteria

1. Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.

2. Those who correspond to any of the following about bowel movements;

• Repeated diarrhea (Bristol Stool Form Score [BSFS] score of 6 or higher) on a daily basis
• Repeated constipation (no defecation for 2 days or more in a week) on a daily basis

3. Those who correspond to any of the following about bowel movements in the 7 days before administration;

• Diarrhea on 2 or more days in 7 days
• 2 or more days without a bowel movement in 7 days

4. Those who have a history of gastrointestinal ulceration

5. Those who correspond to any of the following about infection;

• Positive for SARS-CoV-2 in the nucleic acid amplification test performed at the time of admission
• Suspected of having COVID-19

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taisho Director

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

Taisho Pharmaceutical Co., Ltd selected site

Toshima-ku, , Japan

Countries

Japan

Other Identifiers

TS172-101

Identifier Type: -

Identifier Source: org_study_id