This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.
The purpose of this study is to evaluate the food effect on the pharmacokinetics and safety of a single oral dose of TAK-536TCH under fasted and fed conditions in the morning in healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
TAK-536TCH tablets
Unnamed facility
Fukuoka, Fukuoka, Japan
Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)
Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML
AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.
Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
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Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Urinary excretion ratio (percent \[%\] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Time frame: Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period
Urinary Excretion Ratio of AML
Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Time frame: Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )