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

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Drug: TS-172; Drug: Placebo

• Registration Number: NCT04979572
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-28
• Study Start: 2021-08-16
• Primary Completion: 2022-01-26
• Study Completion: 2022-01-26
• Status Verified: 2022-04
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B (multiple dose) : Step 5: TS-172 90 mg	TS-172	Multiple dose of TS-172 or placebo before breakfast and dinner
Part B (multiple dose) : Step 5: TS-172 90 mg	Placebo	Multiple dose of TS-172 or placebo before breakfast and dinner
Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg	Placebo	Single dose of TS-172 or placebo before breakfast
Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg	TS-172	Single dose of TS-172 or placebo before breakfast

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)	Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11

Secondary Outcome Measures

Name	Time	Method
Concentration of unchanged form in plasma, urine and stool	Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11
Area under the plasma concentration-time curve (AUC) of unchanged form	Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11
Mean daily urinaly excretion of sodium and phosphorus	Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11
Mean daily Bristol Stool Form Scale (BSFS)	Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11	BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Toshima-ku, Japan