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Healthy Male SubjectsPhase 1NCT05621447

A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects

A Phase 1 study testing TAS-303, [14C]TAS-303 in people with Healthy Male Subjects, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-303 following oral single dose Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male Subjects
What is being tested?
TAS-303, [14C]TAS-303
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
7 Sep 2022to 22 Feb 2023
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 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male subjects who provided written informed consent to participate in the study
  • Aged 18 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
  • Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
  • Systolic blood pressure: ≧90 mmHg and ≦139 mmHg, Diastolic blood pressure: ≧40 mmHg and ≦89 mmHg, Pulse rate: ≧40 beats per minute (bpm) and ≦99 bpm, Body temperature: ≧35.0°C and ≦37.4°C

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 evaluations in the study such as asymptomatic pollinosis and wart are excluded)
  • Received a radioisotope-labeled substance or subject to a large quantity of radiation exposure* within 12 months before the first dose of TAS-303.
  • A large quantity of radiation exposure includes continuous X-ray irradiation, computed tomography (CT) scan, gastric barium test, and positron emission tomography (PET) scan, excluding tests with low radiation exposure (e.g., chest, bone, or dental X-ray examination, or X-ray examination before boarding an airplane).
  • Occupationally exposed to radiation within a year before the first dose of TAS-303 (such as operators who are involved in nuclear power or radiation operations).

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • A site selected by Taiho Pharmaceutical Co., Ltd.

    Tokyo

Other trials in Japan

About this study

To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-303 following oral single dose

Being tested
TAS-303, [14C]TAS-303

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS-303, [14C]TAS-303Drug

    oral administration on day 1

Study groups in NCT05621447
Study groupRoleWhat they receive
TAS-303, [14C]TAS-303ExperimentalNot described
Receives: Drug: TAS-303, [14C]TAS-303

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentrations of total radioactivity in blood and plasma

    Measured: Day1 to 8 and 10,12,14,16,18,20,22

  2. Plasma TAS-303 concentrations

    Measured: Day1 to 8 and 10,12,14,16,18,20,22

  3. Maximum plasma concentration (Cmax)

    Measured: Day1 to 8 and 10,12,14,16,18,20,22

  4. Area under the plasma concentration versus time curve (AUC).

    Measured: Day1 to 8 and 10,12,14,16,18,20,22

  5. Elimination half life (T1/2)

    Measured: Day1 to 8 and 10,12,14,16,18,20,22

  6. Radioactivity cumulative excretion rate into urine

    Measured: Day 1 to Day 22

  7. Radioactivity cumulative excretion rate into feces.

    Measured: Day 1 to Day 22

  8. Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).

    Measured: Day 1 to Day 22

Secondary outcomes (8)

  1. Adverse events

    The number and incidence of Adverse events.

    Measured: Day 1 to Day 29

  2. Treatment-related adverse events

    The number and incidence of Treatment-related adverse events.

    Measured: Day 1 to Day 29

  3. Number of Participants With Abnormal Laboratory Values

    Measured: Screening period and Day -2, 8, 15, 22, 29

  4. Blood Pressure

    Measured: Screening period and Day 1, 2, 8, 15, 22, 29

  5. Pulse rate

    Measured: Screening period and Day 1, 8, 15, 22, 29

  6. Temperature

    Measured: Screening period and Day 1, 2, 8, 15, 22, 29

  7. QTc interval

    Measured: Screening period and Day 1, 8, 15, 22, 29

  8. Heart rate

    Measured: Screening period and Day 1, 8, 15, 22, 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start7 Sep 2022
  3. Primary completion3 Nov 2022
  4. Study completion22 Feb 2023

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621447
Sponsor's protocol ID
10060080
Status last verified
Aug 2023
First submitted
30 Oct 2022
Last updated
7 Aug 2023
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAS-303, [14C]TAS-303 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 6 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 7 Aug 2023. 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 (time frame: Day1 to 8 and 10,12,14,16,18,20,22). The study lists 8 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 NCT05621447.

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 7 Aug 2023.

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