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

NCT ID: NCT03042299

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2017-03-11

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.

Detailed Description

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 healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.

Conditions

Japanese Healthy Adult Male Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAK-536 Granules + TAK-536 Tablet

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.

Group Type: EXPERIMENTAL

TAK-536

Intervention Type: DRUG

TAK-536 granules.

TAK-536

Intervention Type: DRUG

TAK-536 tablet.

TAK-536 Tablet + TAK-536 Granules

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.

Group Type: EXPERIMENTAL

TAK-536

Intervention Type: DRUG

TAK-536 granules.

TAK-536

Intervention Type: DRUG

TAK-536 tablet.

Interventions

TAK-536

TAK-536 granules.

Intervention Type: DRUG

TAK-536

TAK-536 tablet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.

2. Signs and dates a written, informed consent form prior to the initiation of any study procedures.

3. Is a Japanese healthy adult male.

4. Aged 20 to 35 years, inclusive, at the time of informed consent.

5. 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.

Exclusion Criteria

1. 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.

2. Has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.

3. Has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.

4. 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.

5. Has a known hypersensitivity to any component of the formulation of TAK-536 or any angiotensin II receptor blocker (ARB).

6. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.

7. 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.

8. Has taken any excluded medication, supplements, dietary products, or food products during the time periods specified in the protocol.

9. 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).

10. 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.

11. 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. Has poor peripheral venous access.

13. 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.

14. 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.

15. Has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1.

16. Has an abnormal (clinically significant) ECG at Screening or prior to the study drug administration in Period 1.

17. Has abnormal laboratory values that suggest a clinically significant underlying disease, or participant with the following laboratory abnormalities at Screening or prior to the study drug administration in Period 1: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>) 1.5 * the upper limits of normal (ULN).

18. Who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Nishi Kumamoto Hospital

Kumamoto, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1190-0845

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-173503

Identifier Type: REGISTRY

Identifier Source: secondary_id

Azilsartan-1004

Identifier Type: -

Identifier Source: org_study_id