A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)
Terminated
Merck Sharp & Dohme Corp.
Phase 1
2012-02-27
The study is designed to investigate the effects of the investigational drug vibegron
(MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive
bladder. The study will also evaluate the safety and tolerability of multiple oral doses of
vibegron in women with overactive bladder. Overactive bladder is best described as urgency
and frequency of urination, with or without involuntary urination and/or the need to awaken
during the night to urinate.
The primary efficacy hypothesis is that vibegron is superior to placebo with respect to
change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e.,
steady state) in participants with overactive bladder. A true mean increase
(vibegron/placebo) of 25% in bladder volume is expected.
The primary safety hypothesis is that administration of multiple oral doses of vibegron is
sufficiently well-tolerated in participants with overactive bladder, based on assessment of
clinical and laboratory adverse experiences, to permit continued clinical investigation.
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