A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03042299
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Days): 29
• Patients Per Site Per Month: 14.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Japanese Healthy Adult Male Participants	Drug: TAK-536; Drug: TAK-536	Phase 1

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Healthy Adult Male Subjects
• Actual Study Start Date: Feb 10, 2017
• Actual Primary Completion Date: Mar 11, 2017
• Actual Study Completion Date: Mar 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAK-536 Granules + TAK-536 Tablet 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.	Drug: TAK-536; TAK-536 granules.; Drug: TAK-536; TAK-536 tablet.
Experimental: 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.	Drug: TAK-536; TAK-536 granules.; Drug: TAK-536; TAK-536 tablet.

Outcome Measures

Primary Outcome Measures

1. 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)]

2. 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)]

Secondary Outcome Measures

1. 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)]

2. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) 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)]

3. 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)]

4. 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)]

5. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [Baseline up to Day 6 of Intervention Period 2 (Day 18)]

   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.

6. Number of Participants With TEAEs Related to Vital Signs [Baseline up to Day 6 of Intervention Period 2 (Day 18)]

7. Number of Participants With TEAEs Related to Body Weight [Baseline up to Day 6 of Intervention Period 2 (Day 18)]

8. Number of Participants With TEAEs Related to Electrocardiograms (ECGs) [Baseline up to Day 6 of Intervention Period 2 (Day 18)]

9. Number of Participants With TEAEs Related to Clinical Laboratory Tests [Baseline up to Day 6 of Intervention Period 2 (Day 18)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.

2. Signs and dates a written, informed consent form prior to the initiation of any study procedures.

3. Is a Japanese healthy adult male.

4. Aged 20 to 35 years, inclusive, at the time of informed consent.

5. Weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m^2), inclusive, at Screening.

Exclusion Criteria:

1. Has suspected hypotension with associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on the day before the study drug administration (Day -1) in Period 1, or up to the study drug administration on the Period 1.

2. Has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.

3. Has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.

4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.

5. Has a known hypersensitivity to any component of the formulation of TAK-536 or any angiotensin II receptor blocker (ARB).

6. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.

7. 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 visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.

8. Has taken any excluded medication, supplements, dietary products, or food products during the time periods specified in the protocol.

9. Has any current or recent (within 6 months) gastrointestinal diseases that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention).

10. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1 of Period 1.

11. 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.

12. Has poor peripheral venous access.

13. Has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study drug administration in Period 1.

14. Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of the study drug administration in Period 1.

15. Has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1.

16. Has an abnormal (clinically significant) ECG at Screening or prior to the study drug administration in Period 1.

17. Has abnormal laboratory values that suggest a clinically significant underlying disease, or participant with the following laboratory abnormalities at Screening or prior to the study drug administration in Period 1: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>) 1.5 * the upper limits of normal (ULN).

18. Who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nishi Kumamoto Hospital	Kumamoto		Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

• Study Protocol - Dec 22, 2016
• Statistical Analysis Plan - May 18, 2017

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT03042299
• Other Study ID Numbers: Azilsartan-1004; U1111-1190-0845; JapicCTI-173503
• First Posted: Feb 3, 2017
• Last Update Posted: Nov 14, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Takeda: Drug therapy
• Additional relevant MeSH terms: Azilsartan medoxomil

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 1 investigative site in Japan from 10 February 2017 to 11 March 2017.
Pre-assignment Detail	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).

Arm/Group Title	TAK-536 Granules + TAK-536 Tablet	TAK-536 Tablet + TAK-536 Granules
Arm/Group Description	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.	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.
Period Title: Intervention Period 1 (6 Days)
STARTED	7	7
COMPLETED	7	7
NOT COMPLETED	0	0
Period Title: Intervention Period 1 (6 Days)
STARTED	7	7
COMPLETED	7	7
NOT COMPLETED	0	0
Period Title: Intervention Period 1 (6 Days)
STARTED	7	7
COMPLETED	7	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	TAK-536 Granules + TAK-536 Tablet	TAK-536 Tablet + TAK-536 Granules	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	7	7	14
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.3 (0.95)	21.3 (1.38)	21.3 (1.14)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	7 100%	7 100%	14 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Japan	7 100%	7 100%	14 100%
Height (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]	167.7 (3.64)	171.3 (4.42)	169.5 (4.31)
Weight (kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram (kg)]	59.97 (5.586)	60.49 (6.838)	60.23 (6.005)
Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per square meter (kg/m^2)]	21.33 (2.072)	20.61 (2.143)	20.97 (2.060)
Smoking classification (Count of Participants)
Never smoked	5 71.4%	4 57.1%	9 64.3%
Current smoker	1 14.3%	3 42.9%	4 28.6%
Ex-smoker	1 14.3%	0 0%	1 7.1%
Alcohol classification (Count of Participants)
Drank a few times per week	1 14.3%	2 28.6%	3 21.4%
Drank a few times per month	4 57.1%	3 42.9%	7 50%
Never drank	2 28.6%	2 28.6%	4 28.6%
Caffeine classification (Count of Participants)
Had caffeine consumption	1 14.3%	2 28.6%	3 21.4%
Had no caffeine consumption	6 85.7%	5 71.4%	11 78.6%

Outcome Measures

1. Primary Outcome

Title	AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Mean (Standard Deviation) [hour*nanogram per milliliter (h*ng/mL)]	6053.7 (1119.60)	6479.6 (1008.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAK-536 10 mg Granules (Pediatric Formulation), TAK-536 10 mg Tablet (Commercial Formulation)
	Comments
	Type of Statistical Test	Equivalence
	Comments	The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Point estimate
	Estimated Value	-0.0731
	Confidence Interval	(2-Sided) 90%; -0.1088 to -0.0373
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Cmax: Maximum Observed Plasma Concentration for TAK-536
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]	803.3 (113.63)	878.1 (117.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAK-536 10 mg Granules (Pediatric Formulation), TAK-536 10 mg Tablet (Commercial Formulation)
	Comments
	Type of Statistical Test	Equivalence
	Comments	The difference in the LS means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Point estimate
	Estimated Value	-0.0909
	Confidence Interval	(2-Sided) 90%; -0.1573 to -0.0244
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Mean (Standard Deviation) [h*ng/mL]	6187.4 (1167.72)	6627.4 (1061.66)

4. Secondary Outcome

Title	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Mean (Standard Deviation) [hours]	1.89 (0.738)	2.43 (0.958)

5. Secondary Outcome

Title	MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Mean (Standard Deviation) [hours]	9.781 (1.4010)	10.11 (1.1873)

6. Secondary Outcome

Title	Terminal Disposition Phase Rate Constant (λz) for TAK-536
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Mean (Standard Deviation) [liter per hour (L/h)]	0.06866 (0.0046324)	0.06862 (0.0077457)

7. Secondary Outcome

Title	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Description	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.
Time Frame	Baseline up to Day 6 of Intervention Period 2 (Day 18)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all participants who received the study drug.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Count of Participants [Participants]	0 0%	0 0%

8. Secondary Outcome

Title	Number of Participants With TEAEs Related to Vital Signs
Time Frame	Baseline up to Day 6 of Intervention Period 2 (Day 18)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all the participants who received the study drug.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With TEAEs Related to Body Weight
Time Frame	Baseline up to Day 6 of Intervention Period 2 (Day 18)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all the participants who received the study drug.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Count of Participants [Participants]	0 0%	0 0%

10. Secondary Outcome

Title	Number of Participants With TEAEs Related to Electrocardiograms (ECGs)
Time Frame	Baseline up to Day 6 of Intervention Period 2 (Day 18)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all the participants who received the study drug.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Count of Participants [Participants]	0 0%	0 0%

11. Secondary Outcome

Title	Number of Participants With TEAEs Related to Clinical Laboratory Tests
Time Frame	Baseline up to Day 6 of Intervention Period 2 (Day 18)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all the participants who received the study drug.

Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)	TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.	TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Measure Participants	14	14
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	TEAEs were assessed after the first dose of study drug until the follow up examination on Day 6 in Intervention Period 2 (Day 18)
Adverse Event Reporting Description	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.
Arm/Group Title	TAK-536 10 mg Granules (Pediatric Formulation)		TAK-536 10 mg Tablet (Commercial Formulation)
Arm/Group Description	TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.		TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
All Cause Mortality
	TAK-536 10 mg Granules (Pediatric Formulation)		TAK-536 10 mg Tablet (Commercial Formulation)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Serious Adverse Events
	TAK-536 10 mg Granules (Pediatric Formulation)		TAK-536 10 mg Tablet (Commercial Formulation)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	TAK-536 10 mg Granules (Pediatric Formulation)		TAK-536 10 mg Tablet (Commercial Formulation)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.