The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron formulations with three different release rates versus three doses of mirabegron administered intravenously; to study safety and side effects of the oral and IV doses of mirabegron.
Subjects will be randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of six treatment sequences. For all subjects the first treatment will be a reference IV dose. Treatments 2, 3, and 4 will be a random order of slow, fast and target release oral doses of mirabegron. Treatment 5 will be a target release dose of mirabegron from a different batch. There will be at least 10 day washout between dose administrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
91
oral tablet
IV solution
Unnamed facility
Tacoma, Washington, United States
Characterize the pharmacokinetic profile of 3 doses of oral mirabegron formulations with three different release rates vs. three doses of mirabegron administered intravenously
Time frame: 2 months
Assess the safety and tolerability of three doses of orally administered mirabegron formulated with three different release rates
Time frame: 2 months
Assess the safety and tolerability of intravenously administered mirabegron
Time frame: 2 months
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