A Bioequivalence Study of TAK-536 Pediatric Formulation

NCT02401464 | Completed Phase 1 Results

• 3 other identifiers: TAK-536/CPH-101U1111-1168-3113JapicCTI-152853
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Japanese Healthy Adult Males

Outcome Measures

Primary Outcomes (4)

• AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort

  Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort

  Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

• AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort

  Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort

  Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

Secondary Outcomes (5)

• Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

  Baseline up to Day 6 of Intervention Period 2

• Number of Participants With TEAEs Related to Vital Signs

  Baseline up to Day 6 of Intervention Period 2

• Number of Participants With TEAEs Related to Body Weight

  Baseline up to Day 6 of Intervention Period 2

• Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)

  Baseline up to Day 6 of Intervention Period 2

• Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values

  Baseline up to Day 6 of Intervention Period 2

Study Arms (4)

Dry syrup formulation (Group a)

EXPERIMENTAL

One pack of the dry syrup formulation of TAK-536, containing 10 milligram (mg) of TAK-536, will be orally administered with water (200 milliliter \[mL\]) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.

Drug: TAK-536 Tablet; Drug: TAK-536 Dry Syrup Formulation

Dry syrup formulation (Group b)

EXPERIMENTAL

One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the dry syrup formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.

Drug: TAK-536 Tablet; Drug: TAK-536 Dry Syrup Formulation

Granule formulation (Group a)

EXPERIMENTAL

One pack of the granule formulation of TAK-536, containing 10 mg of TAK-536,will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.

Drug: TAK-536 Tablet; Drug: TAK-536 Ganule Formulation

Granule formulation (Group b)

EXPERIMENTAL

One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the granule formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.

Drug: TAK-536 Tablet; Drug: TAK-536 Ganule Formulation

Interventions

TAK-536 Tablet DRUG

TAK-536 10 mg tablet

Dry syrup formulation (Group a); Dry syrup formulation (Group b); Granule formulation (Group a); Granule formulation (Group b)

TAK-536 Dry Syrup Formulation DRUG

TAK-536 dry syrup formulation

Dry syrup formulation (Group a); Dry syrup formulation (Group b)

TAK-536 Ganule Formulation DRUG

TAK-536 granule formulation

Granule formulation (Group a); Granule formulation (Group b)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
• The participant is a healthy Japanese adult male volunteer.
• The participant is between 20 and 35 years of age at the time of informed consent.
• 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.

You may not qualify if:

• 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.
• The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study medication for Period 1
• The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
• 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.
• The participant has a known hypersensitivity to TAK-536 or angiotensin II receptor blockers.
• The participant has positive results in the urine drug screening test at screening.
• 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.
• The participant has taken any excluded medication, supplements, or food products during the time periods.
• 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).
• The participant has a history of cancer.
• 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.
• The participant has poor peripheral venous access.
• 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.
• 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.
• The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration for Period 1.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Kagoshima, Japan

Location

MeSH Terms

Interventions

azilsartan

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-05

Locations

JP (1)