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

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: Placebo; Drug: TS-172

Study type: Interventional

Funder types: Industry

Identifiers

NCT04979572

TS172-101

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

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

Experimental group

Description:

Single dose of TS-172 or placebo before breakfast

Treatment:

Drug: TS-172

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: TS-172

Drug: Placebo