NCT03434977

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-536	TAK-536 granule formulation

Timeline

• Start date: 2018-02-14
• Primary completion: 2018-03-11
• Completion: 2018-03-11
• First posted: 2018-02-15
• Last updated: 2019-06-10
• Results posted: 2019-06-07

Locations

1 site across 1 country: Japan