A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation

NCT03042299 | Completed Phase 1 Results

• 3 other identifiers: Azilsartan-1004U1111-1190-0845JapicCTI-173503
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.

Conditions

Japanese Healthy Adult Male Participants

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

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

  Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)

• Cmax: Maximum Observed Plasma Concentration for TAK-536

  Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)

Secondary Outcomes (9)

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536

  Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536

  Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)

• MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536

  Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)

• Terminal Disposition Phase Rate Constant (λz) for TAK-536

  Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)

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

  Baseline up to Day 6 of Intervention Period 2 (Day 18)

Study Arms (2)

TAK-536 Granules + TAK-536 Tablet

EXPERIMENTAL

TAK-536 10 milligram (mg), granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.

Drug: TAK-536

TAK-536 Tablet + TAK-536 Granules

EXPERIMENTAL

TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.

Drug: TAK-536

Interventions

TAK-536 DRUG

TAK-536 granules.

TAK-536 Granules + TAK-536 Tablet; TAK-536 Tablet + TAK-536 Granules

Eligibility Criteria

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

You may qualify if:

• In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
• Signs and dates a written, informed consent form prior to the initiation of any study procedures.
• Is a Japanese healthy adult male.
• Aged 20 to 35 years, inclusive, at the time of informed consent.
• Weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2), inclusive, at Screening.

You may not qualify if:

• Has suspected hypotension with associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on the day before the study drug administration (Day -1) in Period 1, or up to the study drug administration on the Period 1.
• Has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.
• Has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
• Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
• Has a known hypersensitivity to any component of the formulation of TAK-536 or any angiotensin II receptor blocker (ARB).
• Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.
• 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 is unwilling to agree to abstain from alcohol and drugs throughout the study.
• Has taken any excluded medication, supplements, dietary products, or food products during the time periods specified in the protocol.
• Has any current or recent (within 6 months) gastrointestinal diseases that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention).
• Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1 of Period 1.
• 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.
• Has poor peripheral venous access.
• Has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study drug administration in Period 1.
• Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of the study drug administration in Period 1.
• Has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Nishi Kumamoto Hospital

Kumamoto, Japan

Location

MeSH Terms

Interventions

azilsartan

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study 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: February 1, 2017
• First Posted: February 3, 2017
• Study Start: February 10, 2017
• Primary Completion: March 11, 2017
• Study Completion: March 11, 2017
• Last Updated: November 14, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)