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

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ClinicalTrials.gov Identifier: NCT02348658
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: TAK-536TCH Phase 1

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Subjects
Study Start Date : January 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Fasted dosing followed by fed dosing
Dosing in the fasted state followed by fed dosing
Drug: TAK-536TCH
TAK-536TCH tablets

Fed dosing followed by fasted dosing
Dosing in the fed state followed by fasted dosing
Drug: TAK-536TCH
TAK-536TCH tablets




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 [ Time Frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period ]
    AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.

  4. AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML [ Time Frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period ]
    AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.

  5. 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 [ Time Frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period ]
    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]).

  6. 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 [ Time Frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period ]
    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]).

  7. 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 [ Time Frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period ]
    AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.

  8. AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML [ Time Frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period ]
    AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.

  9. Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ [ Time Frame: Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period ]
    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.

  10. Urinary Excretion Ratio of AML [ Time Frame: Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period ]
    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.


Secondary Outcome Measures :
  1. 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 ) ]
  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 ) ]
  3. 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 ) ]
  4. 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 ) ]
  5. Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration [ Time Frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 ) ]
    Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. In the opinion of the investigator and subinvestigator, 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 healthy Japanese 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) from 18.5 to 25.0 kilograms per square meter (kg/m^2), inclusive at Screening.

Exclusion Criteria:

  1. Participant has systolic blood pressure less-than (<) 90 millimeters of mercury (mmHg) at Screening.
  2. Participant has suspected hypotension and associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on Day -1 of Period 1, or up to administration on the Period 1.
  3. The participant has received any study drug within 16 weeks (that is [i.e.], 112 days) prior to study drug administration of Period 1.
  4. The participant has received TAK-491*, TAK-536, amlodipine, or hydrochlorothiazide in a previous clinical study or as a therapeutic agent.
  5. The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine disease, or other abnormality (other than the disease studied), which could impact the ability of the participant to participate or potentially confound the study results.
  6. Participant has a known hypersensitivity to drugs.
  7. Participant has a positive urine drug result for drugs of abuse at Screening.
  8. 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 was unwilling to agree to abstain from alcohol and drugs throughout the study.
  9. Participant required any prohibited concomitant drugs, vitamins, or food products listed in the prohibited concomitant drugs and foods table.
  10. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).
  11. Participant has a history of cancer.
  12. 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.
  13. Participant has poor peripheral venous access.
  14. 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 study drug administration in Period 1.
  15. Participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to study drug administration in Period 1.
  16. Participant has undergone blood component collection within 2 weeks (14 days) prior to study drug administration in Period 1.
  17. Participant has a hemoglobin value of less than 12.5 g/dL in laboratory testing at Screening or prior to study drug administration in Period 1.
  18. Participant has a clinically significant ECG abnormality at Screening or prior to study drug administration in Period 1.
  19. Participant has abnormal laboratory values at Screening or prior to study drug administration of Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is >1.5-fold the upper limits of normal range.
  20. Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348658


Locations
Japan
Fukuoka-shi, Fukuoka, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Study Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02348658     History of Changes
Other Study ID Numbers: TAK-536TCH/CPH-004
U1111-1165-5595 ( Registry Identifier: WHO )
JapicCTI-152777 ( Registry Identifier: JapicCTI )
First Posted: January 28, 2015    Key Record Dates
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016
Last Verified: March 2016

Keywords provided by Takeda:
Pharmacological therapy