Healthy Adult SubjectsPhase 1NCT04979572
A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)
A Phase 1 study testing TS-172 in people with Healthy Adult Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- TS-172
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteJapan
- Study dates
- 16 Aug 2021to 26 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- TS-172, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-172Drug
- 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
PlaceboDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg | Experimental | Single dose of TS-172 or placebo before breakfast Receives: Drug: TS-172; Drug: Placebo |
| Part B (multiple dose) : Step 5: TS-172 90 mg | Experimental | Multiple dose of TS-172 or placebo before breakfast and dinner Receives: Drug: TS-172; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
Measured: 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 (4)
Concentration of unchanged form in plasma, urine and stool
Measured: 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
Measured: Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11
Mean daily urinaly excretion of sodium and phosphorus
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start16 Aug 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979572
- Sponsor's protocol ID
- TS172-101
- Status last verified
- Apr 2022
- First submitted
- 5 Jul 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04979572
- Acronym / sponsor ID
- TS172-101
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg | Experimental | Drug: TS-172, Drug: PlaceboSingle dose of TS-172 or placebo before breakfast |
| Part B (multiple dose) : Step 5: TS-172 90 mg | Experimental | Drug: TS-172, Drug: PlaceboMultiple dose of TS-172 or placebo before breakfast and dinner |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
- Those who correspond to any of the following about bowel movements in the 7 days before administration;
- Those who have a history of gastrointestinal ulceration
- Those who correspond to any of the following about infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg, Part B (multiple dose) : Step 5: TS-172 90 mg |
| 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 | Drug | Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg, Part B (multiple dose) : Step 5: TS-172 90 mg |
Primary outcome
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
4 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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Healthy Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taisho Director study director
Taisho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TS-172 in people with Healthy Adult Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.