CompletedNCT04979572Updated Feb 28, 2025

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

A Phase 1 interventional study of TS-172 and Placebo in Healthy Adult Subjects, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 41
Allocation: Randomized
Ages: 20 Years to 39 Years
Sex: Male

Study 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 studied

Healthy Adult Subjects

In context

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 39 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent
Those with a BMI of 18.5 or more and less than 25.0 at screening test
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

Exclusion Criteria:

Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
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
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
Those who have a history of gastrointestinal ulceration
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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 41 participants (actual)

Study arms

Experimental
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
Drug: TS-172 · Drug: Placebo
Experimental
Part B (multiple dose) : Step 5: TS-172 90 mg
Multiple dose of TS-172 or placebo before breakfast and dinner
Drug: TS-172 · Drug: Placebo

Interventions

DrugTS-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
DrugPlacebo
* 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

What researchers measure

Primary outcomes

Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
Time frame: 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 outcomes

Concentration of unchanged form in plasma, urine and stool
Time frame: 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
Time frame: Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11
Mean daily urinaly excretion of sodium and phosphorus
Time frame: 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)
BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool
Time frame: 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

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04979572
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Jul 28, 2021
Start date: Aug 16, 2021
Primary completion: Jan 26, 2022
Completion: Jan 26, 2022
Last update: Feb 28, 2025

Study contacts

Taisho Director

study director · Taisho Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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