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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1190-0845 | Registry Identifier | WHO | |
| JapicCTI-173503 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-536 Granules + TAK-536 Tablet | Experimental | TAK-536 10 milligram (mg), granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
|
| TAK-536 Tablet + TAK-536 Granules | Experimental | TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-536 | Drug | TAK-536 granules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536 | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) | |
| Cmax: Maximum Observed Plasma Concentration for TAK-536 | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishi Kumamoto Hospital | Kumamoto | Japan |
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Healthy male participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive TAK-536 10 milligram (mg) granules (pediatric formulation) or TAK-536 10 mg tablet (commercial formulation).
Participants took part in the study at 1 investigative site in Japan from 10 February 2017 to 11 March 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-536 Granules + TAK-536 Tablet | TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
| FG001 | TAK-536 Tablet + TAK-536 Granules | TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 (6 Days) |
| |||||||||||||
| Washout Period (at Least 6 Days) |
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| Intervention Period 2 (6 Days) |
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The safety analysis set included all participants who received the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-536 Granules + TAK-536 Tablet | TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536 | The pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK. | Posted | Mean | Standard Deviation | hour*nanogram per milliliter (h*ng/mL) | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
|
TEAEs were assessed after the first dose of study drug until the follow up examination on Day 6 in Intervention Period 2 (Day 18)
At each visit the investigator or sub-investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator or sub-investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-536 10 mg Granules (Pediatric Formulation) | TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2016 | Feb 23, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2017 | Feb 23, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
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| TAK-536 | Drug | TAK-536 tablet. |
|
| Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
| MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536 | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
| Terminal Disposition Phase Rate Constant (λz) for TAK-536 | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
| Number of Participants With TEAEs Related to Vital Signs | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
| Number of Participants With TEAEs Related to Body Weight | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
| Number of Participants With TEAEs Related to Electrocardiograms (ECGs) | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
| Number of Participants With TEAEs Related to Clinical Laboratory Tests | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
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| NOT COMPLETED |
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| BG001 |
| TAK-536 Tablet + TAK-536 Granules |
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Smoking classification | Count of Participants | Participants |
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| Alcohol classification | Count of Participants | Participants |
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| Caffeine classification | Count of Participants | Participants |
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TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2. |
|
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|
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-536 | The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
|
|
|
|
| Secondary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 | The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 | The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK. | Posted | Mean | Standard Deviation | hours | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
|
|
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| Secondary | MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536 | The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK. | Posted | Mean | Standard Deviation | hours | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
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|
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| Secondary | Terminal Disposition Phase Rate Constant (λz) for TAK-536 | The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK. | Posted | Mean | Standard Deviation | liter per hour (L/h) | Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) |
|
|
|
| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | The safety analysis set included all participants who received the study drug. | Posted | Count of Participants | Participants | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
|
|
|
| Secondary | Number of Participants With TEAEs Related to Vital Signs | The safety analysis set included all the participants who received the study drug. | Posted | Count of Participants | Participants | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
|
|
|
| Secondary | Number of Participants With TEAEs Related to Body Weight | The safety analysis set included all the participants who received the study drug. | Posted | Count of Participants | Participants | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
|
|
|
| Secondary | Number of Participants With TEAEs Related to Electrocardiograms (ECGs) | The safety analysis set included all the participants who received the study drug. | Posted | Count of Participants | Participants | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
|
|
|
| Secondary | Number of Participants With TEAEs Related to Clinical Laboratory Tests | The safety analysis set included all the participants who received the study drug. | Posted | Count of Participants | Participants | Baseline up to Day 6 of Intervention Period 2 (Day 18) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | TAK-536 10 mg Tablet (Commercial Formulation) | TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2. | 0 | 14 | 0 | 14 | 0 | 14 |
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.