Healthy Japanese Adult MalePhase 1NCT02322606
A Phase 1, Single and Multiple Dose Study of TAK-137
A Phase 1 study of Healthy Japanese Adult Male, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of TAK-137 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese Adult Male
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2014to May 2015
- 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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant eligibility is determined according to the following criteria prior to entry into the study:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, ICF and any required privacy authorization prior to the initiation of any study procedures.
- The participant is a healthy Japanese adult male volunteer.
- The participant is between 20 and 45 years of age at the time of informed consent.
- The participant has a body weight of at least 50 kg and has a body mass index (BMI) between 18.5 and 24.9 kg/m2 at the time of screening and baseline (Day -1).
- A male participant who is sexually active with a female partner of childbearing potential agrees to use adequate contraception after signing the ICF for up to 12 weeks from the last dose.
Who cannot join
- Any participant who meets any of the following criteria will not qualify for entry into the study:
- The participant has received any investigational drugs within 30 days prior to the first study drug administration.
- The participant has received TAK-137 in a previous clinical study.
- The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
- The participant has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion
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- The participant has a history of psychiatric disorders.
- The participant has a known hypersensitivity to medication(s) or food(s).
- The participant has positive results in the urine drug screening test at screening.
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the screening or is unwilling to agree to abstain from alcohol and drugs throughout the study period.
- The participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products during the screening period, or requires such medication or food during the study.
- The participant intends to donate sperm from the signing of ICF to 12 weeks after the last dose.
- The participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention, [e.g. gastrectomy, cholecystectomy, etc.]).
- The subject has a history of cancer.
- The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening.
- The subject has poor peripheral venous access.
- The subject has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the first study drug administration.
- The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the first study drug administration.
- The participant has undergone blood component collection within 2 weeks (14 days) prior to the first study drug administration.
- The participant has any clinically significant ECG abnormality at time of screening or baseline (Day -1).
- The participant has abnormal screening or baseline (Day -1) laboratory values that suggest a clinically significant underlying disease, or the participant has the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 × the upper limits of normal (ULN).
- The participant has an abnormal EEG during screening
- The participant is at risk for suicide based on the investigator's determination.
- The participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of TAK-137 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of TAK-137 in healthy male subjects.
Read the detailed description
This study is a phase 1, randomized, placebo-controlled, double-blind, multiple ascending dose study in Japanese healthy male participants to assess the safety, tolerability and PK following single and multiple oral doses of TAK-137.
This study is composed of 2 parts, a Single Dose part (Cohorts 1 to 3) and a Multiple Dose part (Cohorts 4 to 6). Up to 48 participants will be enrolled.
Single dose part (Cohorts 1-3): Single Dose, 3 dose levels, Placebo-Controlled, Randomized, Double-Blind.
Each cohort will include 8 participants. Participants will be randomly assigned to either TAK-137 or placebo treatment group within each cohort with an allocation ratio of 6:2.
The planned dose levels to be studied are 5, 10 and 20 mg. The principal investigator will consult with the sponsor and the medical specialist as needed and will determine go/no-go for the next cohort.. The dose in Cohorts 3 may be reduced to 2 mg/day instead of 20 mg/day if the principal investigator, in consultation with the sponsor, considers it appropriate.
Multiple dose Part (Cohorts 4-6): Multiple Dose, 3 dose levels, Placebo-Controlled, Randomized, Double-Blind.
Each cohort will include 8 participants. Participants will be randomly assigned to either TAK-137 or placebo treatment group within each cohort with an allocation ratio of 6:2.
The planned dose levels to be studied are 5, 10,and 15 mg, however for Cohort 5 and 6, the dose level may be amended based on the safety and tolerability data obtained from either Cohorts 1-4 from this study or emerging data from the multiple rising dose study conducted, in parallel in the United Sates (TAK-137_102). The principle investigator, in consultation with the sponsor, will determine the dose levels for cohorts 5 and 6 (Not exceeding 20mg).
- Conditions
- Healthy Japanese Adult Male
- Being tested
- TAK-137 5 mg tablet, TAK-137 placebo tablet, TAK-137 5 mg tablet, TAK-137 placebo tablet or TAK-137 0.5 mg tablet, TAK-137 placebo tablet, TAK-137 5mg tablet, TAK-137 placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-137 5 mg tablet, TAK-137 placebo tabletDrug
TAK-137 5 mg tablet, TAK-137 placebo tabletDrug
TAK-137 5 mg tablet, TAK-137 placebo tablet or TAK-137 0.5 mg tablet, TAK-137 placebo tabletDrug
TAK-137 5mg tablet, TAK-137 placebo tabletDrug
TAK-137 5 mg tablet, TAK-137 placebo tabletDrug
TAK-137 5mg tablet, TAK-137 placebo tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: TAK-137 5 mg, TAK-137 placebo | Other | Single-dose administration in a fasting state Receives: Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet |
| Cohort 2: TAK-137 10 mg, TAK-137 placebo tablet | Other | Single-dose administration in a fasting state Receives: Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet |
| Cohort 3: TAK-137 20 mg or TAK-137 2 mg + TAK-137 placebo | Other | Single-dose administration in a fasting state Receives: Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet or TAK-137 0.5 mg tablet, TAK-137 placebo tablet |
| Cohort 4: TAK-137 5mg, TAK-137 placebo | Other | Once daily for 7 days in a fasting state Receives: Drug: TAK-137 5mg tablet, TAK-137 placebo tablet |
| Cohort 5: TAK-137 10 mg, TAK-137 placebo | Other | Once daily for 7 days in a fasting state Receives: Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet |
| Cohort 6: TAK-137 15 mg, TAK-137 placebo | Other | Once daily for 7 days in a fasting state Receives: Drug: TAK-137 5mg tablet, TAK-137 placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of Adverse events (Single dose Part)
The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-137. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-137.
Measured: Up to 8 days
Frequencies of Adverse events (Multiple dose Part)
The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-137. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-137.
Measured: Up to 14 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for vital sign measurements at least once post-dose (Single dose Part)
Measured: Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for vital sign measurements at least once post-dose (Multiple dose Part)
Measured: Up to 9 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for body weight measurements at least once post-dose (Single dose Part)
Measured: Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for body weight measurements at least once post-dose (Multiple dose Part)
Measured: Up to 9 days
Percentage of participants with abnormal and clinically significant judged by investigator for electrocardiogram measurements at least once post-dose (Single dose Part)
The percentage of participants with abnormal and clinically significant judged by investigator, electrocardiogram measurements during the study period.
Measured: Up to 8 days
Percentage of participants with abnormal and clinically significant judged by investigator for electrocardiogram measurements at least once post-dose (Multiple dose Part)
The percentage of participants with abnormal and clinically significant judged by investigator, electrocardiogram measurements during the study period.
Measured: Up to 9 days
Percentage of participants with significantly abnormal (epileptiform) judged by investigator for electroencephalogram measurements at least once post-dose (Single dose Part)
The percentage of participants with significantly abnormal (epileptiform) judged by investigator, electroencephalogram measurements during the study period.
Measured: Up to 1 day
Percentage of participants with significantly abnormal (epileptiform) judged by investigator for electroencephalogram measurements at least once post-dose (Multiple dose Part)
The percentage of participants with significantly abnormal (epileptiform) judged by investigator, electroencephalogram measurements during the study period.
Measured: Up to 7 days
Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose (Single dose Part)
The percentage of participants with any markedly abnormal, standard safety laboratory values, including hematology and serum chemistries during the study period.
Measured: Up to 8 days
Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose (Multiple dose Part)
The percentage of participants with any markedly abnorma, standard safety laboratory values, including hematology and serum chemistries during the study period.
Measured: Up to 9 days
Descriptive statistics (mean, SD, median, minimum and maximum) of observed value for Stimulant relapse risk scale (excerpt) (Single dose Part)
Measured: Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of observed value for Stimulant relapse risk scale (excerpt) (Multiple dose Part )
Measured: Up to 9 days
Secondary outcomes (3)
Descriptive statistics (mean, SD, median, minimum and maximum) of pharmacokinetic parameters (AUC(0-168), AUC(0-tlqc), Cmax, Tmax, AUC(0-inf), T1/2, CL/F, Vz/F and MR) for unchanged TAK-137 and its metabolite M-I in plasma (Single dose Part)
The pharmacokinetic parameters (AUC(0-168), AUC(0-tlqc), Cmax, Tmax, AUC(0-inf), T1/2, CL/F, Vz/F and MR) will be estimated from a Non-compartmental analysis.
Measured: Days 1-8
Descriptive statistics (mean, SD, median, min. and max.) of pharmacokinetic parameters for unchanged TAK-137 and its metabolite M-I in plasma (Multiple dose Part)
The pharmacokinetic parameters (AUC(0-24), AUC(0-tlqc), Cmax, Tmax, AUC(0-inf), T1/2, CL/F, Vz/F, MR, Cavg, R(AUC), R(Cmax), AI(AUC) and AI(T1/2)) will be estimated from a Non-compartmental analysis.
Measured: Days 1-9
Descriptive statistics (mean, SD, median, minimum and maximum) of pharmacokinetic parameters (Fe and CLr) for unchanged TAK-137 and its metabolite M-I in urine (Single dose Part)
Measured: Days 1-4 (Prior to administration and 0-24, 24-48, 48-72 hours after administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese Adult MaleStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322606
- Sponsor's protocol ID
- TAK-137/CPH-001
- Other IDs
- U1111-1162-5936
- Status last verified
- Nov 2015
- First submitted
- 28 Oct 2014
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of TAK-137 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02322606
- Acronym / sponsor ID
- TAK-137/CPH-001
- Conditions
- Healthy Japanese Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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.
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of TAK-137 in healthy male subjects.
Detailed description
This study is a phase 1, randomized, placebo-controlled, double-blind, multiple ascending dose study in Japanese healthy male participants to assess the safety, tolerability and PK following single and multiple oral doses of TAK-137.
This study is composed of 2 parts, a Single Dose part (Cohorts 1 to 3) and a Multiple Dose part (Cohorts 4 to 6). Up to 48 participants will be enrolled.
Single dose part (Cohorts 1-3): Single Dose, 3 dose levels, Placebo-Controlled, Randomized, Double-Blind.
Each cohort will include 8 participants. Participants will be randomly assigned to either TAK-137 or placebo treatment group within each cohort with an allocation ratio of 6:2.
The planned dose levels to be studied are 5, 10 and 20 mg. The principal investigator will consult with the sponsor and the medical specialist as needed and will determine go/no-go for the next cohort.. The dose in Cohorts 3 may be reduced to 2 mg/day instead of 20 mg/day if the principal investigator, in consultation with the sponsor, considers it appropriate.
Multiple dose Part (Cohorts 4-6): Multiple Dose, 3 dose levels, Placebo-Controlled, Randomized, Double-Blind.
Each cohort will include 8 participants. Participants will be randomly assigned to either TAK-137 or placebo treatment group within each cohort with an allocation ratio of 6:2.
The planned dose levels to be studied are 5, 10,and 15 mg, however for Cohort 5 and 6, the dose level may be amended based on the safety and tolerability data obtained from either Cohorts 1-4 from this study or emerging data from the multiple rising dose study conducted, in parallel in the United Sates (TAK-137_102). The principle investigator, in consultation with the sponsor, will determine the dose levels for cohorts 5 and 6 (Not exceeding 20mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TAK-137 5 mg, TAK-137 placebo | Other | Drug: TAK-137 5 mg tablet, TAK-137 placebo tabletSingle-dose administration in a fasting state |
| Cohort 2: TAK-137 10 mg, TAK-137 placebo tablet | Other | Drug: TAK-137 5 mg tablet, TAK-137 placebo tabletSingle-dose administration in a fasting state |
| Cohort 3: TAK-137 20 mg or TAK-137 2 mg + TAK-137 placebo | Other | Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet or TAK-137 0.5 mg tablet, TAK-137 placebo tabletSingle-dose administration in a fasting state |
| Cohort 4: TAK-137 5mg, TAK-137 placebo | Other | Drug: TAK-137 5mg tablet, TAK-137 placebo tabletOnce daily for 7 days in a fasting state |
| Cohort 5: TAK-137 10 mg, TAK-137 placebo | Other | Drug: TAK-137 5 mg tablet, TAK-137 placebo tabletOnce daily for 7 days in a fasting state |
| Cohort 6: TAK-137 15 mg, TAK-137 placebo | Other | Drug: TAK-137 5mg tablet, TAK-137 placebo tabletOnce daily for 7 days in a fasting state |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant eligibility is determined according to the following criteria prior to entry into the study:
Key exclusion criteria (24 listed)
- Any participant who meets any of the following criteria will not qualify for entry into the study:
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 |
|---|---|---|
| TAK-137 5 mg tablet, TAK-137 placebo tablet | Drug | Cohort 1: TAK-137 5 mg, TAK-137 placebo |
| TAK-137 5 mg tablet, TAK-137 placebo tablet | Drug | Cohort 2: TAK-137 10 mg, TAK-137 placebo tablet |
| TAK-137 5 mg tablet, TAK-137 placebo tablet or TAK-137 0.5 mg tablet, TAK-137 placebo tablet | Drug | Cohort 3: TAK-137 20 mg or TAK-137 2 mg + TAK-137 placebo |
| TAK-137 5mg tablet, TAK-137 placebo tablet | Drug | Cohort 4: TAK-137 5mg, TAK-137 placebo |
| TAK-137 5 mg tablet, TAK-137 placebo tablet | Drug | Cohort 5: TAK-137 10 mg, TAK-137 placebo |
| TAK-137 5mg tablet, TAK-137 placebo tablet | Drug | Cohort 6: TAK-137 15 mg, TAK-137 placebo |
Primary outcome
Frequencies of Adverse events (Single dose Part)
Time frame: Up to 8 days
The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-137. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-137.
Frequencies of Adverse events (Multiple dose Part)
Time frame: Up to 14 days
The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-137. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-137.
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for vital sign measurements at least once post-dose (Single dose Part)
Time frame: Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for vital sign measurements at least once post-dose (Multiple dose Part)
Time frame: Up to 9 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for body weight measurements at least once post-dose (Single dose Part)
Time frame: Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for body weight measurements at least once post-dose (Multiple dose Part)
Time frame: Up to 9 days
Percentage of participants with abnormal and clinically significant judged by investigator for electrocardiogram measurements at least once post-dose (Single dose Part)
Time frame: Up to 8 days
The percentage of participants with abnormal and clinically significant judged by investigator, electrocardiogram measurements during the study period.
Percentage of participants with abnormal and clinically significant judged by investigator for electrocardiogram measurements at least once post-dose (Multiple dose Part)
Time frame: Up to 9 days
The percentage of participants with abnormal and clinically significant judged by investigator, electrocardiogram measurements during the study period.
Percentage of participants with significantly abnormal (epileptiform) judged by investigator for electroencephalogram measurements at least once post-dose (Single dose Part)
Time frame: Up to 1 day
The percentage of participants with significantly abnormal (epileptiform) judged by investigator, electroencephalogram measurements during the study period.
Percentage of participants with significantly abnormal (epileptiform) judged by investigator for electroencephalogram measurements at least once post-dose (Multiple dose Part)
Time frame: Up to 7 days
The percentage of participants with significantly abnormal (epileptiform) judged by investigator, electroencephalogram measurements during the study period.
Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose (Single dose Part)
Time frame: Up to 8 days
The percentage of participants with any markedly abnormal, standard safety laboratory values, including hematology and serum chemistries during the study period.
Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose (Multiple dose Part)
Time frame: Up to 9 days
The percentage of participants with any markedly abnorma, standard safety laboratory values, including hematology and serum chemistries during the study period.
Descriptive statistics (mean, SD, median, minimum and maximum) of observed value for Stimulant relapse risk scale (excerpt) (Single dose Part)
Time frame: Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of observed value for Stimulant relapse risk scale (excerpt) (Multiple dose Part )
Time frame: Up to 9 days
3 secondary outcomes
Descriptive statistics (mean, SD, median, minimum and maximum) of pharmacokinetic parameters (AUC(0-168), AUC(0-tlqc), Cmax, Tmax, AUC(0-inf), T1/2, CL/F, Vz/F and MR) for unchanged TAK-137 and its metabolite M-I in plasma (Single dose Part)
Time frame: Days 1-8
Descriptive statistics (mean, SD, median, min. and max.) of pharmacokinetic parameters for unchanged TAK-137 and its metabolite M-I in plasma (Multiple dose Part)
Time frame: Days 1-9
Descriptive statistics (mean, SD, median, minimum and maximum) of pharmacokinetic parameters (Fe and CLr) for unchanged TAK-137 and its metabolite M-I in urine (Single dose Part)
Time frame: Days 1-4 (Prior to administration and 0-24, 24-48, 48-72 hours after administration)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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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.
General Manager study director
Takeda
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 of Healthy Japanese Adult Male, run by Takeda 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 7 inclusion and 24 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: withdrawn, as of the sponsor's last update on 26 Nov 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Frequencies of Adverse events (Single dose Part) (time frame: Up to 8 days). The study lists 14 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 26 Nov 2015.