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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1206-5973 | Other Identifier | WHO | |
| JapicCTI-183856 | Registry Identifier | JapicCTI |
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The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants.
The drug being tested in this study is called TAK-536. TAK-536 is being tested in Japanese healthy adult male participants. This study will look at the PK and effect of food on the PK following single oral administration of TAK-536 pediatric formulation.
The study will enroll 12 healthy participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups and will receive a single oral dose of 10 mg of TAK-536 pediatric formulation with 200 mL of water according to the following treatments in each period during the study.
This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately one month. Participants will make five visits to the clinic and be hospitalized for eight days in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-536 10 mg (fasted) + TAK-536 10 mg (fed) | Experimental | TAK-536 10 milligram (mg) granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) in the morning under fasted condition, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) after starting breakfast. |
|
| TAK-536 10 mg (fed) + TAK-536 10 mg (fasted) | Experimental | TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) after starting breakfast, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) in the morning under fasted condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-536 | Drug | TAK-536 granule formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| 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 (up to 48 hours) post-dose | |
| T1/2z: Terminal Disposition Phase Half-life for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| λz: Terminal Disposition Phase Rate Constant for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| CL/F: Apparent Clearance for TAK-536 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Baseline up to Day 18 (End of Period 2) | |
| Number of Participants With TEAE Related to Vital Sign | Baseline up to Day 18 (End of Period 2) |
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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 |
|---|---|---|---|---|---|---|
| Fukuoka Mirai Hospital | Fukuoka | Japan |
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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 pediatric formulation of TAK-536 10 milligram (mg) granules under fasted or fed condition.
Participants took part in the study at 1 investigative site in Japan from 14 February 2018 to 11 March 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules Fed | TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 2. |
| FG001 | TAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted | TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 (6 Days) |
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| Washout Period (at Least 6 Days) |
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| Intervention Period 2 (6 Days) |
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The safety analysis set was defined as all participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules Fed | TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Cmax: Maximum Observed Plasma Concentration for TAK-536 | The pharmacokinetic (PK) analysis set was defined as 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 (up to 48 hours) post-dose |
|
TEAEs are adverse events that started after the first dose of study drug until the follow up examination on Day 6 in Period 2 (Day 18)
At each visit the 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 was recorded, irrespective of the relation to study treatment.
Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.
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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 Fasted | TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of either Period 1 or 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophil count increased | Investigations | MedDRA (20.0) | Systematic Assessment |
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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 8, 2017 | Mar 6, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2018 | Mar 6, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
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| Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Vz/F: Apparent Volume of Distribution for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Number of Participants With TEAE Related to Body Weight | Baseline up to Day 18 (End of Period 2) |
| Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased) | Baseline up to Day 18 (End of Period 2) |
| Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs) | Baseline up to Day 18 (End of Period 2) |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| TAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted |
TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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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| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 | The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK. | Posted | Median | Full Range | hours | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
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| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 | The PK analysis set was defined as 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 (up to 48 hours) post-dose |
|
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| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 | The PK analysis set was defined as 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 (up to 48 hours) post-dose |
|
|
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| Primary | T1/2z: Terminal Disposition Phase Half-life for TAK-536 | The PK analysis set was defined as 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 (up to 48 hours) post-dose |
|
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|
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| Primary | MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 | The PK analysis set was defined as 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 (up to 48 hours) post-dose |
|
|
|
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| Primary | MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536 | The PK analysis set was defined as 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 (up to 48 hours) post-dose |
|
|
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| Primary | λz: Terminal Disposition Phase Rate Constant for TAK-536 | The PK analysis set was defined as 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 | 1 per hour (1/h) | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
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| Primary | CL/F: Apparent Clearance for TAK-536 | The PK analysis set was defined as 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 (up to 48 hours) post-dose |
|
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| Primary | Vz/F: Apparent Volume of Distribution for TAK-536 | The PK analysis set was defined as 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 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
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| Secondary | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to adverse event (AE) before the start of Period 2. | Posted | Count of Participants | Participants | Baseline up to Day 18 (End of Period 2) |
|
|
|
| Secondary | Number of Participants With TEAE Related to Vital Sign | The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2. | Posted | Count of Participants | Participants | Baseline up to Day 18 (End of Period 2) |
|
|
|
| Secondary | Number of Participants With TEAE Related to Body Weight | The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2. | Posted | Count of Participants | Participants | Baseline up to Day 18 (End of Period 2) |
|
|
|
| Secondary | Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased) | The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2. | Posted | Count of Participants | Participants | Baseline up to Day 18 (End of Period 2) |
|
|
|
| Secondary | Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs) | The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2. | Posted | Count of Participants | Participants | Baseline up to Day 18 (End of Period 2) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | TAK-536 10 mg Granules Fed | TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of either Period 1 or 2. | 0 | 12 | 0 | 12 | 1 | 12 |
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.