A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03434977
• Date of registration: 08/02/2018
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation
• Scientific title: A Randomized, Open-Label, Cross-over Phase 1 Study to Evaluate the Food Effect of Single Oral Dose of TAK-536 Pediatric Formulation in Healthy Adult Male Subjects
• Date of first enrolment: February 14, 2018
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03434977
• 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. The participant signs and dates a written, informed consent form prior to the
initiation of any study procedures.

3. The participant is a Japanese healthy adult male.

4. The participant ages 20 to 35 years inclusive at the time of informed consent.

5. The participant 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. The participant 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 in Period 1.

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

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

4. The participant 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. The participant has a hypersensitivity to any component of the formulation of TAK-536
or any ARB.

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

7. 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 visit or is unwilling
to agree to abstain from alcohol and drugs throughout the study.

8. The participant has taken any excluded medication, supplements, dietary products or
food products during the specified time periods.

9. The participant has any current or recent (within 6 months prior to the start of the
study drug administration in Period 1) 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. The participant 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. The participant has a positive test result for hepatitis B virus surface antigen
(HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV)
antibody/antigen, or serological reactions for syphilis at Screening.

12. The participant has poor peripheral venous access.

13. The participant 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. The participant 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. The participant has undergone blood component collection within 2 weeks (14 days)
prior to the start of the study drug administration in Period 1.

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

17. The participant 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 Transaminase (AST) greater than (>) 1.5× the
upper limits of normal (ULN).

18. The participant 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

Healthy Volunteers

Intervention(s)

Drug: TAK-536

Primary Outcome(s)

T1/2z: Terminal Disposition Phase Half-life for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

Vz/F: Apparent Volume of Distribution for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

MRT8, ev: Mean Residence Time From Time 0 to Infinity for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

?z: Terminal Disposition Phase Rate Constant for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

CL/F: Apparent Clearance for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

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 (up to 48 hours) post-dose]

Cmax: Maximum Observed Plasma Concentration for TAK-536 [Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

Secondary Outcome(s)

Number of Participants With TEAE Related to Vital Sign [Time Frame: Baseline up to Day 18 (End of Period 2)]

Number of Participants With TEAE Related to Body Weight [Time Frame: Baseline up to Day 18 (End of Period 2)]

Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased) [Time Frame: Baseline up to Day 18 (End of Period 2)]

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) [Time Frame: Baseline up to Day 18 (End of Period 2)]

Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs) [Time Frame: Baseline up to Day 18 (End of Period 2)]

Secondary ID(s)

U1111-1206-5973

JapicCTI-183856

Azilsartan-1005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03434977