Japanese healthy adult male participants
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-536 pediatric formulation (granules), commercial formulation
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Dos
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements. 2.The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3.The participant is a Japanese healthy adult male. 4.The participant is aged 20 to 35 years, inclusive, at the time of informed consent. 5.The participant weighs at least 50.0 kg, and has a body mass index (BMI) between 18.5 and 25.0 kg/m^2, inclusive, at Screening.
Exclusion criteria
Exclusion criteria: 1.The participant 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.The participant has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1. 3.The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent. 4.The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results. 5.The participant has a known hypersensitivity to any component of the formulation of TAK-536 or any ARB. 6.The participant has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening. 7.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 visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. 8.The participant has taken any excluded medication, supplements, dietary products, or food products during the time periods listed in the table. 9.The participant has any current or recent (within 6 months) gastrointestinal diseases 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). 10.The participant 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.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. 12.The participant has poor peripheral venous access. 13.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 the study drug administration in Period 1. 14.The participant 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.The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1. 16.The participant has an abnormal (clinically significant) ECG at Screening or prior to the study drug administration in Period 1. 17.The participant 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) >1.5 x the upper limits of normal (ULN). 18.The participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-48): Area Under the Plasma Concentration-Time Curve from Time 0 to 48 Hours for TAK-536 Timeframe; Day 1 : pre-dose and at multiple timepoints (up to 48 hours) post-dose Cmax : Maximum Observed Plasma Concentration for TAK-536 Timeframe; Day 1 : pre-dose and at multiple timepoints (up to 48 hours) post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (0-infinity) : Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity for TAK-536 Timeframe; Day 1 : pre-dose and at multiple timepoints (up to 48 hours) post-dose tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 Timeframe; Day 1 : pre-dose and at multiple timepoints (up to 48 hours) post-dose MRT : Mean Residence Time after Extravascular Administration from Time 0 to 48 Hours Quantifiable Concentration for TAK-536 Timeframe; Day 1 : pre-dose and at multiple timepoints (up to 48 hours) post-dose Lz : Terminal Disposition Phase Rate Constant for TAK-536 Timeframe; Day 1 : pre-dose and at multiple timepoints (up to 48 hours) post-dose Number of Participants who had One or More Treatment Emergent Adverse Event (TEAE) Timeframe; Up to Day 6 Number of Participants With TEAE Related to Vital Signs Vital signs include sitting blood pressure, sitting pulse (beats per minute), and body temperature. Timeframe; Up to Day 6 Number of Participants With TEAE Related to Weight Timeframe; Up to Day 6 Number of Participants With TEAE Related to Resting 12-Lead ECGs Timeframe; Up to Day 6 Number of Participants With TEAE Related to laboratory test results (hematology, serum chemistry, and urinalysis) Timeframe; Up to Day 6 | — |
Outcome results
None listed