Healthy ParticipantsPhase 1NCT03591133
Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)
A Phase 1 study testing TS-143 in people with Healthy Participants, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals. 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 Participants
- What is being tested?
- TS-143
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 24 Dec 2015to 14 Apr 2016
- 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
- Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests
- Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted prior to the investigational drug treatment
Who cannot join
- Subjects who meet any of the following criteria in the screening tests or the tests conducted on Day -1 and prior to the investigational drug treatment
- Red blood cell count: ≥ 535 × 10^4 /μL
- Hemoglobin: ≥ 16.2 g/dL
- Hematocrit: ≥ 47.5%
- Reticulocyte ratio: Outside of the reference value range
- Subjects who meet any of the following criteria in the screening tests
Show all 12Show fewer
- Serum EPO concentration: Outside of the reference value range
- Ferritin: 30 ng/mL or less, or ≥ 262 ng/mL
- Subjects who meet any of the following criteria in the vital signs in the screening tests and the tests conducted prior to the investigational drug treatment
- Blood pressure: Systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg or more
- Pulse rate: < 40 bpm, or ≥ 100 bpm
- Body temperature: ≥ 37.5°C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)
To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.
- Conditions
- Healthy Participants
- Being tested
- TS-143, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-143Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Step1:3㎎ QD | Other | Drug: TS-143 3mg Drug: Placebo Receives: Drug: TS-143; Drug: Placebo |
| Step2:6㎎ QD | Other | Drug: TS-143 6mg Drug: Placebo Receives: Drug: TS-143; Drug: Placebo |
| Step3-1:11㎎ QD | Other | Drug: TS-143 11mg Drug: Placebo Receives: Drug: TS-143; Drug: Placebo |
| Step3-2:11㎎ QD（Fed) | Other | Drug: TS-143 11mg Drug: Placebo Receives: Drug: TS-143; Drug: Placebo |
| Step4:20㎎ QD | Other | Drug: TS-143 20mg Drug: Placebo Receives: Drug: TS-143; Drug: Placebo |
| Step5:36㎎ QD | Other | Drug: TS-143 36mg Drug: Placebo Receives: Drug: TS-143; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Measured: 8 days
Plasma concentrations of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Measured: 72 hours
Urinary excretions of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group.
Measured: 72 hours
Serum erythropoietin (EPO) concentration
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start24 Dec 2015
- Primary completion14 Apr 2016
- Study completion14 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Okuyama, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591133
- Sponsor's protocol ID
- TS143-01-01
- Status last verified
- Jun 2023
- First submitted
- 18 Apr 2018
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.
PubMed 30176654
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
- Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)
- ClinicalTrials.gov ID
- NCT03591133
- Acronym / sponsor ID
- TS143-01-01
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2015 (actual)
- Primary completion
- 14 Apr 2016 (actual)
- Study completion
- 14 Apr 2016 (actual)
- First posted
- 19 Jul 2018 (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.
To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Step1:3㎎ QD | Other | Drug: TS-143, Drug: PlaceboDrug: TS-143 3mg Drug: Placebo |
| Step2:6㎎ QD | Other | Drug: TS-143, Drug: PlaceboDrug: TS-143 6mg Drug: Placebo |
| Step3-1:11㎎ QD | Other | Drug: TS-143, Drug: PlaceboDrug: TS-143 11mg Drug: Placebo |
| Step3-2:11㎎ QD（Fed) | Other | Drug: TS-143, Drug: PlaceboDrug: TS-143 11mg Drug: Placebo |
| Step4:20㎎ QD | Other | Drug: TS-143, Drug: PlaceboDrug: TS-143 20mg Drug: Placebo |
| Step5:36㎎ QD | Other | Drug: TS-143, Drug: PlaceboDrug: TS-143 36mg Drug: Placebo |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests
- Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted prior to the investigational drug treatment
Key exclusion criteria (12 listed)
- Subjects who meet any of the following criteria in the screening tests or the tests conducted on Day -1 and prior to the investigational drug treatment
- Subjects who meet any of the following criteria in the screening tests
- Subjects who meet any of the following criteria in the vital signs in the screening tests and the tests conducted prior to the investigational drug treatment
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-143 | Drug | Step1:3㎎ QD, Step2:6㎎ QD, Step3-1:11㎎ QD, Step3-2:11㎎ QD（Fed), Step4:20㎎ QD, Step5:36㎎ QD |
| Placebo | Drug | Step1:3㎎ QD, Step2:6㎎ QD, Step3-1:11㎎ QD, Step3-2:11㎎ QD（Fed), Step4:20㎎ QD, Step5:36㎎ QD |
Primary outcome
Incidence of adverse events
Time frame: 8 days
To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Plasma concentrations of unchanged form (ng/mL)
Time frame: 72 hours
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Urinary excretions of unchanged form (ng/mL)
Time frame: 72 hours
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group.
Serum erythropoietin (EPO) concentration
Time frame: 72 hours
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.
- Results publication: PubMed 30176654Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.
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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.
Shigeru Okuyama 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-143 in people with Healthy Participants, 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 2 inclusion and 12 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 adverse events (time frame: 8 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591133, which also lists 1 linked publication.
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.