Healthy Male SubjectsPhase 1NCT04825431
Mass Balance Study of [14C] TAS-205 in Healthy Volunteers
A Phase 1 study testing TAS-205, [14C]TAS-205 in people with Healthy Male Subjects, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-205 following oral single doses. 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 Male Subjects
- What is being tested?
- TAS-205, [14C]TAS-205
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 22 Mar 2021to 27 May 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
- Healthy adult male who provided written informed consent to participate in the study
- Aged 20 years or older and younger than 40 years at the time of informed consent
- Capable of oral intake.
- Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
Who cannot join
- Had current or previous hypersensitivity or allergy to drugs
- Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- Had any concurrent disease (including symptoms and signs; however, diseases that do not affect valuations in the study such as asymptomatic pollinosis and wart are excluded)
- Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
- Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
- Systolic blood pressure: <90 mmHg or ≥140 mmHg, Diastolic blood pressure: <40 mmHg or ≥90 mmHg, Pulse rate: <40 beats per minute (bpm) or ≥100 bp, Body temperature: 35.0°C or ≥37.1°C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-label Study Evaluating the Pharmacokinetics and Mass Balance of [14C] TAS-205 in Healthy Volunteers
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-205 following oral single doses.
- Conditions
- Healthy Male Subjects
- Being tested
- TAS-205, [14C]TAS-205
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-205, [14C]TAS-205Drug
single oral administration under fasted conditions on day 1
| Study group | Role | What they receive |
|---|---|---|
| TAS-205, [14C]TAS-205 | Experimental | Not described Receives: Drug: TAS-205, [14C]TAS-205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
Measured: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces.
Measured: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
Measured: Day 1 to Day 8
Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Mar 2021
- Primary completion15 Jun 2021
- Study completion27 May 2022
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 Male 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taiho Pharmaceutical Co., Ltd., Study director, Taiho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825431
- Sponsor's protocol ID
- 10053070
- Status last verified
- Aug 2022
- First submitted
- 28 Mar 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical\_trial\_information\_disclosure\_policy/index.html.
Publications
Hanada R, Takenaka T. Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor. Clin Pharmacol Drug Dev. 2025 Mar;14(3):200-208. doi: 10.1002/cpdd.1504. Epub 2025 Jan 22.
PubMed 39840517
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study Evaluating the Pharmacokinetics and Mass Balance of [14C] TAS-205 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04825431
- Acronym / sponsor ID
- 10053070
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 1 Apr 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.
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-205 following oral single doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-205, [14C]TAS-205 | Experimental | Drug: TAS-205, [14C]TAS-205 |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male who provided written informed consent to participate in the study
- Aged 20 years or older and younger than 40 years at the time of informed consent
- Capable of oral intake.
- Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
Key exclusion criteria (6 listed)
- Had current or previous hypersensitivity or allergy to drugs
- Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- Had any concurrent disease (including symptoms and signs; however, diseases that do not affect valuations in the study such as asymptomatic pollinosis and wart are excluded)
- Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
- Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
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 |
|---|---|---|
| TAS-205, [14C]TAS-205single oral administration under fasted conditions on day 1 | Drug | TAS-205, [14C]TAS-205 |
Primary outcome
Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
Time frame: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces.
Time frame: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
Time frame: Day 1 to Day 8
Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.
Time frame: Day 1 to Day 8
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 8 Aug 2022.
- Derived from this study: PubMed 39840517Hanada R, Takenaka T. Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor. Clin Pharmacol Drug Dev. 2025 Mar;14(3):200-208. doi: 10.1002/cpdd.1504. Epub 2025 Jan 22.
- Individual participant dataSharing planned: No. Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.
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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.
Taiho Pharmaceutical Co., Ltd. study director
Taiho 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 TAS-205, [14C]TAS-205 in people with Healthy Male Subjects, run by Taiho 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 4 inclusion and 6 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 8 Aug 2022. 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?
Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205 (time frame: Day 1 to Day 8). 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 NCT04825431, 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 8 Aug 2022.