A Bioequivalence Study of TAK-536 Pediatric Formulation | NCT02401464

NCT02401464

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
U1111-1168-3113	Registry Identifier	WHO
JapicCTI-152853	Registry Identifier	JapicCTI

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	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.

Name	Type	Description	Arm Group Labels	Other Names
TAK-536 Tablet	Drug	TAK-536 10 mg tablet	Dry syrup formulation (Group a) Dry syrup formulation (Group b) Granule formulation (Group a)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort		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		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		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		Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)		Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Related to Vital Signs		Baseline up to Day 6 of Intervention Period 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Name	Affiliation	Role
Medical Director	Takeda	Study Director

Arm/Group Information

ID	Title	Description
FG000	Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet	Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
FG001	Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup	Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
FG002	Granule Cohort: TAK-536 Granules + TAK-536 Tablet	Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
FG003	Granule Cohort: TAK-536 Tablet + TAK-536 Granules	Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet	Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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 in Dry Syrup Cohort

The pharmacokinetic 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 pharmacokinetics.

Posted

Mean

Standard Deviation

nanogram*hour per milliliter (ng*hr/mL)

Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

ID	Title	Description
OG000	Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation	Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
OG001	Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation	Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).