Clinical trial NCT02401464: A Bioequivalence Study of TAK-536 Pediatric Formulation
Official title: A Randomized, Open-label, 2×2 Crossover, Phase I Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-536 Pediatric Formulations and TAK-536 Commercial Tablet in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Japanese Healthy Adult Males
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 52
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: The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male participants.

Detailed description: This study was designed to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation (dry syrup, granules) and a single oral dose of TAK-536 commercial tablet by using open-label, 2 × 2 crossover design.

Eligibility criteria: Inclusion Criteria:

1. In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
3. The participant is a healthy Japanese adult male volunteer.
4. The participant is between 20 and 35 years of age at the time of informed consent.
5. The participant has a body weight of at least 50.0 kilogram (kg) and has a body mass index (BMI) between 18.5 and 25.0 kilogram per meter square (kg/m\^2) at the time of screening.

Exclusion Criteria:

1. The participant has shown symptoms of dizziness on standing up, facial pallor, cold sweat, etc, and suspected hypotension at medical examination/physical findings at screening and the day before administration of the study drug for Period 1, and before administration of the study drug for Period 1.
2. The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study medication for 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, urologic or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
5. The participant has a known hypersensitivity to TAK-536 or angiotensin II receptor blockers.
6. The participant has positive results in the urine drug screening test 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 or is unwilling to agree to abstain from alcohol and drugs throughout the study period.
8. The participant has taken any excluded medication, supplements, or food products during the time periods.
9. The participant has current or recent (within 6 months) gastrointestinal disease 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 (ie, cholecystectomy).
10. The participant has a history of cancer.
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 study medication administration for 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 study medication administration for Period 1.
15. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration for Period 1.
16. The participant has an abnormal (clinically significant) electro-cardiogram at screening or prior to the start of study medication for Period 1.
17. The participant has abnormal laboratory values at screening or prior to the start of study medication for Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine transaminase (ALT) or aspartate transaminase (AST) greater than (\>)1.5 times the upper limits of normal.
18. The participant who, in the opinion of the investigator or the sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Primary outcomes:
measure: AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort
timeFrame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort
timeFrame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
measure: AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort
timeFrame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort
timeFrame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Secondary outcomes:
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 6 of Intervention Period 2
measure: Number of Participants With TEAEs Related to Vital Signs
timeFrame: Baseline up to Day 6 of Intervention Period 2
measure: Number of Participants With TEAEs Related to Body Weight
timeFrame: Baseline up to Day 6 of Intervention Period 2
measure: Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
timeFrame: Baseline up to Day 6 of Intervention Period 2
measure: Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
timeFrame: Baseline up to Day 6 of Intervention Period 2
Other outcomes:
Locations:
city: Kagoshima
country: Japan
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: