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

NCT03434977 | Completed Phase 1 Results

• 3 other identifiers: Azilsartan-1005U1111-1206-5973JapicCTI-183856
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (10)

• Cmax: Maximum Observed Plasma Concentration for TAK-536

  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

  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

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• T1/2z: Terminal Disposition Phase Half-life for TAK-536

  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

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• λz: Terminal Disposition Phase Rate Constant for TAK-536

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• CL/F: Apparent Clearance for TAK-536

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• Vz/F: Apparent Volume of Distribution for TAK-536

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Secondary Outcomes (5)

• Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

  Baseline up to Day 18 (End of Period 2)

• Number of Participants With TEAE Related to Vital Sign

  Baseline up to Day 18 (End of Period 2)

• Number of Participants With TEAE Related to Body Weight

  Baseline up to Day 18 (End of Period 2)

• Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)

  Baseline up to Day 18 (End of Period 2)

• Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)

  Baseline up to Day 18 (End of Period 2)

Study Arms (2)

TAK-536 10 mg (fasted) + TAK-536 10 mg (fed)

EXPERIMENTAL

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 10 mg (fed) + TAK-536 10 mg (fasted)

EXPERIMENTAL

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

Interventions

TAK-536 DRUG

TAK-536 granule formulation

TAK-536 10 mg (fasted) + TAK-536 10 mg (fed); TAK-536 10 mg (fed) + TAK-536 10 mg (fasted)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
• The participant is a Japanese healthy adult male.
• The participant ages 20 to 35 years inclusive at the time of informed consent.
• 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.

You may not qualify if:

• 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.
• The participant has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.
• The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
• 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.
• The participant has a hypersensitivity to any component of the formulation of TAK-536 or any ARB.
• The participant has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.
• 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.
• The participant has taken any excluded medication, supplements, dietary products or food products during the specified time periods.
• 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).
• 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.
• 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.
• The participant has poor peripheral venous access.
• 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.
• 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.
• The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Fukuoka Mirai Hospital

Fukuoka, Japan

Location

MeSH Terms

Interventions

azilsartan

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 15, 2018
• Study Start: February 14, 2018
• Primary Completion: March 11, 2018
• Study Completion: March 11, 2018
• Last Updated: June 10, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)