Japanese Healthy Adult MalesPhase 1NCT02401464
A Bioequivalence Study of TAK-536 Pediatric Formulation
A Phase 1 study testing TAK-536 Tablet, TAK-536 Dry Syrup Formulation and TAK-536 Ganule Formulation in people with Japanese Healthy Adult Males, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male participants. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Japanese Healthy Adult Males
- What is being tested?
- TAK-536 Tablet, TAK-536 Dry Syrup Formulation and TAK-536 Ganule Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2015to May 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form (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 35 years of age at the time of informed consent.
- The participant has a body weight of at least 50.0 kilogram (kg) and has a body mass index (BMI) between 18.5 and 25.0 kilogram per meter square (kg/m^2) at the time of screening.
Who cannot join
- The participant has shown symptoms of dizziness on standing up, facial pallor, cold sweat, etc, and suspected hypotension at medical examination/physical findings at screening and the day before administration of the study drug for Period 1, and before administration of the study drug for Period 1.
- The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study medication for Period 1
- The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
- 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 a known hypersensitivity to TAK-536 or angiotensin II receptor blockers.
- The participant has positive results in the urine drug screening test at screening.
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- 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 during the time periods.
- The participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention (ie, cholecystectomy).
- The participant has a history of cancer.
- The participant 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 participant has poor peripheral venous access.
- The participant 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 start of study medication administration for Period 1.
- The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study medication administration for Period 1.
- The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration for Period 1.
- The participant has an abnormal (clinically significant) electro-cardiogram at screening or prior to the start of study medication for Period 1.
- The participant has abnormal laboratory values at screening or prior to the start of study medication for Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine transaminase (ALT) or aspartate transaminase (AST) greater than (>)1.5 times the upper limits of normal.
- The participant who, in the opinion of the investigator or the sub-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 Randomized, Open-label, 2×2 Crossover, Phase I Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-536 Pediatric Formulations and TAK-536 Commercial Tablet in Healthy Adult Male Subjects
The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male participants.
Read the detailed description
This study was designed to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation (dry syrup, granules) and a single oral dose of TAK-536 commercial tablet by using open-label, 2 × 2 crossover design.
- Conditions
- Japanese Healthy Adult Males
- Being tested
- TAK-536 Tablet, TAK-536 Dry Syrup Formulation, TAK-536 Ganule Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-536 TabletDrug
TAK-536 10 mg tablet
TAK-536 Dry Syrup FormulationDrug
TAK-536 dry syrup formulation
TAK-536 Ganule FormulationDrug
TAK-536 granule formulation
| Study group | Role | What they receive |
|---|---|---|
| Dry syrup formulation (Group a) | Experimental | One pack of the dry syrup formulation of TAK-536, containing 10 milligram (mg) of TAK-536, will be orally administered with water (200 milliliter [mL]) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. Receives: Drug: TAK-536 Tablet; Drug: TAK-536 Dry Syrup Formulation |
| Dry syrup formulation (Group b) | Experimental | One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the dry syrup formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. Receives: Drug: TAK-536 Tablet; Drug: TAK-536 Dry Syrup Formulation |
| Granule formulation (Group a) | Experimental | One pack of the granule formulation of TAK-536, containing 10 mg of TAK-536,will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. Receives: Drug: TAK-536 Tablet; Drug: TAK-536 Ganule Formulation |
| Granule formulation (Group b) | Experimental | One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the granule formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. Receives: Drug: TAK-536 Tablet; Drug: TAK-536 Ganule Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort
Measured: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort
Measured: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort
Measured: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort
Measured: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Secondary outcomes (5)
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Related to Vital Signs
Measured: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Related to Body Weight
Measured: Baseline up to Day 6 of Intervention Period 2
Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Measured: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Measured: Baseline up to Day 6 of Intervention Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Japanese Healthy Adult MalesStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401464
- Sponsor's protocol ID
- TAK-536/CPH-101
- Other IDs
- U1111-1168-3113, JapicCTI-152853
- Status last verified
- May 2016
- First submitted
- 24 Mar 2015
- Last updated
- 6 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 2×2 Crossover, Phase I Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-536 Pediatric Formulations and TAK-536 Commercial Tablet in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02401464
- Acronym / sponsor ID
- TAK-536/CPH-101
- Conditions
- Japanese Healthy Adult Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Posted 6 Jul 2016
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 evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male participants.
Detailed description
This study was designed to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation (dry syrup, granules) and a single oral dose of TAK-536 commercial tablet by using open-label, 2 × 2 crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dry syrup formulation (Group a) | Experimental | Drug: TAK-536 Tablet, Drug: TAK-536 Dry Syrup FormulationOne pack of the dry syrup formulation of TAK-536, containing 10 milligram (mg) of TAK-536, will be orally administered with water (200 milliliter [mL]) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
| Dry syrup formulation (Group b) | Experimental | Drug: TAK-536 Tablet, Drug: TAK-536 Dry Syrup FormulationOne 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the dry syrup formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
| Granule formulation (Group a) | Experimental | Drug: TAK-536 Tablet, Drug: TAK-536 Ganule FormulationOne pack of the granule formulation of TAK-536, containing 10 mg of TAK-536,will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
| Granule formulation (Group b) | Experimental | Drug: TAK-536 Tablet, Drug: TAK-536 Ganule FormulationOne 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the granule formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form (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 35 years of age at the time of informed consent.
- The participant has a body weight of at least 50.0 kilogram (kg) and has a body mass index (BMI) between 18.5 and 25.0 kilogram per meter square (kg/m^2) at the time of screening.
Key exclusion criteria (18 listed)
- The participant has shown symptoms of dizziness on standing up, facial pallor, cold sweat, etc, and suspected hypotension at medical examination/physical findings at screening and the day before administration of the study drug for Period 1, and before administration of the study drug for Period 1.
- The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study medication for Period 1
- The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
- 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 a known hypersensitivity to TAK-536 or angiotensin II receptor blockers.
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-536 TabletTAK-536 10 mg tablet | Drug | Dry syrup formulation (Group a), Dry syrup formulation (Group b), Granule formulation (Group a), Granule formulation (Group b) |
| TAK-536 Dry Syrup FormulationTAK-536 dry syrup formulation | Drug | Dry syrup formulation (Group a), Dry syrup formulation (Group b) |
| TAK-536 Ganule FormulationTAK-536 granule formulation | Drug | Granule formulation (Group a), Granule formulation (Group b) |
Primary outcome
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort
Time frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort
Time frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort
Time frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort
Time frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
5 secondary outcomes
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Time frame: Baseline up to Day 6 of Intervention Period 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director 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 testing TAK-536 Tablet, TAK-536 Dry Syrup Formulation and TAK-536 Ganule Formulation in people with Japanese Healthy Adult Males, 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 5 inclusion and 18 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 6 Jul 2016. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort (time frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose). 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?
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 6 Jul 2016.