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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434977
Recruitment Status : Completed
First Posted : February 15, 2018
Results First Posted : June 7, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: TAK-536 Phase 1

Detailed Description:

The drug being tested in this study is called TAK-536. TAK-536 is being tested in Japanese healthy adult male participants. This study will look at the PK and effect of food on the PK following single oral administration of TAK-536 pediatric formulation.

The study will enroll 12 healthy participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups and will receive a single oral dose of 10 mg of TAK-536 pediatric formulation with 200 mL of water according to the following treatments in each period during the study.

  • Treatment Group A: single oral administration in the morning under fasted condition (Period 1), followed by single oral administration after breakfast (Period 2)
  • Treatment Group B: single oral administration after breakfast (Period 1), followed by in the morning under fasted condition (Period 2)

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately one month. Participants will make five visits to the clinic and be hospitalized for eight days in total.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : March 11, 2018
Actual Study Completion Date : March 11, 2018


Arm Intervention/treatment
Experimental: TAK-536 10 mg (fasted) + TAK-536 10 mg (fed)
TAK-536 10 milligram (mg) granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) in the morning under fasted condition, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) after starting breakfast.
Drug: TAK-536
TAK-536 granule formulation

Experimental: TAK-536 10 mg (fed) + TAK-536 10 mg (fasted)
TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) after starting breakfast, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) in the morning under fasted condition.
Drug: TAK-536
TAK-536 granule formulation




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. AUC∞: 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 ]
  5. 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 ]
  6. 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 ]
  7. MRT∞, 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 ]
  8. λz: 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 ]
  9. CL/F: Apparent Clearance for TAK-536 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  10. 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 ]

Secondary Outcome Measures :
  1. Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: Baseline up to Day 18 (End of Period 2) ]
  2. Number of Participants With TEAE Related to Vital Sign [ Time Frame: Baseline up to Day 18 (End of Period 2) ]
  3. Number of Participants With TEAE Related to Body Weight [ Time Frame: Baseline up to Day 18 (End of Period 2) ]
  4. Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased) [ Time Frame: Baseline up to Day 18 (End of Period 2) ]
  5. Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs) [ Time Frame: Baseline up to Day 18 (End of Period 2) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434977


Locations
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Japan
Fukuoka Mirai Hospital
Fukuoka, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] December 8, 2017
Statistical Analysis Plan  [PDF] January 10, 2018

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03434977    
Other Study ID Numbers: Azilsartan-1005
U1111-1206-5973 ( Other Identifier: WHO )
JapicCTI-183856 ( Registry Identifier: JapicCTI )
First Posted: February 15, 2018    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action