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

Japanese Healthy Adult Male Participants Clinical Trial

Official title:

A Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042299
• Other study ID #: Azilsartan-1004
• Secondary ID: U1111-1190-0845J
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2017
• Est. completion date: March 11, 2017

Study information

• Verified date: October 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 11, 2017
• Est. primary completion date: March 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Japanese Healthy Adult Male Participants

Intervention

Drug:
• TAK-536
TAK-536 granules.
• TAK-536
TAK-536 tablet.

Locations

Country	Name	City	State
Japan	Nishi Kumamoto Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	AUC8: 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)
Secondary	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)
Secondary	MRT8,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)
Secondary	Terminal Disposition Phase Rate Constant (?z) 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	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.	Baseline up to Day 6 of Intervention Period 2 (Day 18)
Secondary	Number of Participants With TEAEs Related to Vital Signs		Baseline up to Day 6 of Intervention Period 2 (Day 18)
Secondary	Number of Participants With TEAEs Related to Body Weight		Baseline up to Day 6 of Intervention Period 2 (Day 18)
Secondary	Number of Participants With TEAEs Related to Electrocardiograms (ECGs)		Baseline up to Day 6 of Intervention Period 2 (Day 18)
Secondary	Number of Participants With TEAEs Related to Clinical Laboratory Tests		Baseline up to Day 6 of Intervention Period 2 (Day 18)