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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03042299
• Date of registration: 01/02/2017
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation
• Scientific 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
• Date of first enrolment: February 10, 2017
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03042299
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Japanese Healthy Adult Male Participants

Intervention(s)

Drug: TAK-536

Primary Outcome(s)

Cmax: Maximum Observed Plasma Concentration for TAK-536 [Time Frame: 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)]

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

MRT8,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536 [Time Frame: 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 With TEAEs Related to Vital Signs [Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)]

Number of Participants With TEAEs Related to Clinical Laboratory Tests [Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)]

AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 [Time Frame: 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 With TEAEs Related to Body Weight [Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)]

Terminal Disposition Phase Rate Constant (?z) for TAK-536 [Time Frame: 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 [Time Frame: 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) [Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)]

Number of Participants With TEAEs Related to Electrocardiograms (ECGs) [Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)]

Secondary ID(s)

JapicCTI-173503

U1111-1190-0845

Azilsartan-1004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03042299