Phase 1 N=12 Randomized Treatment

A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02348658 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ) — 1912.0; 1783.7; 448.3; 455.3 nanogram per milliliter (ng/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: TAK-536TCH (Drug)
Age: Adult · 20+ yrs
Sex: Male
Sponsor: Takeda
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)	1912.0; 1783.7; 448.3; 455.3; 453.5; 451.9	—
PRIMARY Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)	3.752; 3.668	—
PRIMARY 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	14599.8; 13279.4; 3215.8; 2693.8; 9093.3; 8990.8	—
PRIMARY AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML	119.370; 125.749	—
PRIMARY 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	14599.8; 13279.4; 3215.8; 2693.8; 9093.3; 8990.8	—
PRIMARY 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	119.370; 125.749	—
PRIMARY 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	15077.4; 13700.9; 3271.3; 2755.1; 10496.0; 10193.0	—
PRIMARY AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML	132.941; 140.484	—
PRIMARY Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ	13.682; 13.080; 0.076; 0.033; 19.275; 19.933	—
PRIMARY Urinary Excretion Ratio of AML	6.843; 7.328	—
SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	1; 1	—
SECONDARY Number of Participants With TEAEs Related to Vital Signs	0; 0	—
SECONDARY Number of Participants With TEAEs Related to Body Weight	0; 0	—
SECONDARY Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values	1; 0	—
SECONDARY Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration	0; 0	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

1. In the opinion of the investigator and subinvestigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
The participant is a healthy Japanese adult male. 4. The participant is aged 20 to 35 years, inclusive at the time of informed consent.
The participant weighs at least 50.0 kg and has a body mass index (BMI) from 18.5 to 25.0 kilograms per square meter (kg/m^2), inclusive at Screening.

Exclusion Criteria

Participant has systolic blood pressure less-than ( 1.5-fold the upper limits of normal range.
Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02348658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.