Healthy Adult MalesPhase 1NCT05691660
A Study of TAS3731 in Healthy Adults
A Phase 1 study testing TAS3731 Dose1, TAS3731 Dose2 and TAS3731 Dose3 in people with Healthy Adult Males, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the safety of single and repeated administration of TAS3731. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Males
- What is being tested?
- TAS3731 Dose1, TAS3731 Dose2 and TAS3731 Dose3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteJapan
- Study dates
- 17 Jan 2023to 21 May 2024
- 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 39 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
- Body weight of 50 kg or more at screening:
- Body mass index of 18.5 or more and less than 25.0 (Japanese) or less than 30.0 kg/m2 (Caucasian)
- Capable of oral intake.
Who cannot join
- Complications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease. The stomach or small intestine has been resected.
- The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.
- 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)
- The patient has the following complications or a history of the following.
- Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- Had current or previous hypersensitivity or allergy to drugs
- Suspected COVID-19 disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults
To evaluate the safety of single and repeated administration of TAS3731.
- Conditions
- Healthy Adult Males
- Being tested
- TAS3731 Dose1, TAS3731 Dose2, TAS3731 Dose3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS3731 Dose1Drug
Oral administration,1 day,QD
TAS3731 Dose2Drug
Oral administration,7 days,QD
TAS3731 Dose3Drug
Oral administration,7 days,BID
PlaceboDrug
Oral administration, 1 day,QD
PlaceboDrug
Oral administration, 7 days,QD
PlaceboDrug
Oral administration, 7 days,BID
| Study group | Role | What they receive |
|---|---|---|
| Single dose cohort | Experimental | Not described Receives: Drug: TAS3731 Dose1; Drug: Placebo |
| Repeated dose cohort Once daily (QD) | Experimental | Not described Receives: Drug: TAS3731 Dose2; Drug: Placebo |
| Repeated dose cohort Twice daily (BID) | Experimental | Not described Receives: Drug: TAS3731 Dose3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and incidence rate of adverse events
Measured: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
The number and incidence rate of adverse drug reactions
Measured: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
Evaluation of Systolic and Diastolic blood pressure
Measured: Single dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 7 days, Repeated dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 16 days
Evaluation of pulse rate
Measured: Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days
Evaluation of body temperature
Measured: Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days
Number of participants with abnormal laboratory values
Measured: Single dose cohort：Change in number of participants with abnormal laboratory values between baseline and 7 days, Repeated dose cohort：Change in number of participants with abnormal laboratory values between baseline and 16 days
Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval
Measured: Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days
Evaluation of RR-interval
Measured: Single dose cohort：Change from Baseline Evaluation of RR-interval at 7 days, Repeated dose cohort：Change from Baseline Evaluation of RR-interval at 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start17 Jan 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MalesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 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
- NCT05691660
- Sponsor's protocol ID
- 10074010
- Status last verified
- Aug 2024
- First submitted
- 24 Nov 2022
- Last updated
- 14 Aug 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05691660
- Acronym / sponsor ID
- 10074010
- Conditions
- Healthy Adult Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 20 Jan 2023 (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 safety of single and repeated administration of TAS3731.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose cohort | Experimental | Drug: TAS3731 Dose1, Drug: Placebo |
| Repeated dose cohort Once daily (QD) | Experimental | Drug: TAS3731 Dose2, Drug: Placebo |
| Repeated dose cohort Twice daily (BID) | Experimental | Drug: TAS3731 Dose3, Drug: Placebo |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Body weight of 50 kg or more at screening:
- Body mass index of 18.5 or more and less than 25.0 (Japanese) or less than 30.0 kg/m2 (Caucasian)
- Capable of oral intake.
Key exclusion criteria (7 listed)
- Complications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease. The stomach or small intestine has been resected.
- The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.
- 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)
- The patient has the following complications or a history of the following.
- Suspected COVID-19 disease.
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 |
|---|---|---|
| TAS3731 Dose1Oral administration,1 day,QD | Drug | Single dose cohort |
| TAS3731 Dose2Oral administration,7 days,QD | Drug | Repeated dose cohort Once daily (QD) |
| TAS3731 Dose3Oral administration,7 days,BID | Drug | Repeated dose cohort Twice daily (BID) |
| PlaceboOral administration, 1 day,QD | Drug | Single dose cohort |
| PlaceboOral administration, 7 days,QD | Drug | Repeated dose cohort Once daily (QD) |
| PlaceboOral administration, 7 days,BID | Drug | Repeated dose cohort Twice daily (BID) |
Primary outcome
The number and incidence rate of adverse events
Time frame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
The number and incidence rate of adverse drug reactions
Time frame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
Evaluation of Systolic and Diastolic blood pressure
Time frame: Single dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 7 days, Repeated dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 16 days
Evaluation of pulse rate
Time frame: Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days
Evaluation of body temperature
Time frame: Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days
Number of participants with abnormal laboratory values
Time frame: Single dose cohort：Change in number of participants with abnormal laboratory values between baseline and 7 days, Repeated dose cohort：Change in number of participants with abnormal laboratory values between baseline and 16 days
Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval
Time frame: Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days
Evaluation of RR-interval
Time frame: Single dose cohort：Change from Baseline Evaluation of RR-interval at 7 days, Repeated dose cohort：Change from Baseline Evaluation of RR-interval at 16 days
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 14 Aug 2024.
- 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 TAS3731 Dose1, TAS3731 Dose2 and TAS3731 Dose3 in people with Healthy Adult Males, 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 5 inclusion and 7 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 14 Aug 2024. 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?
The number and incidence rate of adverse events (time frame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16). 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?
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 14 Aug 2024.