Clinical trial NCT02348658: A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
timeFrame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
measure: Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)
timeFrame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
measure: 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
timeFrame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
measure: AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML
timeFrame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
measure: 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
timeFrame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
measure: 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
timeFrame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
measure: 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
timeFrame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
measure: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML
timeFrame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
measure: Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
timeFrame: Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period
measure: Urinary Excretion Ratio of AML
timeFrame: Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period
Secondary outcomes:
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
measure: Number of Participants With TEAEs Related to Vital Signs
timeFrame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
measure: Number of Participants With TEAEs Related to Body Weight
timeFrame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
measure: Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
timeFrame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
measure: Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration
timeFrame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
state: Fukuoka
Study officials:
affiliation: Takeda
name: Study Manager
role: STUDY_CHAIR
References: