NCT04501640

A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Mirabegron in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants. This study also evaluated the safety and tolerability of single oral doses of mirabegron in healthy Chinese male and female participants.

Detailed description

An open-label, randomized, 2-period, single oral dose crossover design at 2 dose levels in healthy Chinese male and female participants. Each participant took part in 2 periods separated by a washout of at least 10 days between investigational product (IP) administrations in each period. Participants were screened for up to 21 days prior to IP administration on day 1 of period 1. Eligible participants were admitted to the clinical unit on day -1 of each period and were confined until the last pharmacokinetic sample had been drawn within each period. PK samples were collected predose on day 1 of each period and at multiple time points following each dose.

Conditions

• Pharmacokinetics of Mirabegron
• Food Effect
• Healthy Chinese Subjects

Interventions

Type	Name	Description
DRUG	mirabegron	Oral adminstration

Timeline

• Start date: 2020-09-21
• Primary completion: 2020-10-14
• Completion: 2020-10-27
• First posted: 2020-08-06
• Last updated: 2024-11-12
• Results posted: 2021-10-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study