This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.
This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing. The study consists of a 21-day screening period for subject eligibility followed by a 1-day double-blind period in which all subjects receive a single open-label dose of 1.75 mg SC BMT after receiving a single blinded dose of Zofran (ondansetron) 8 mg or placebo. Approximately 228 subjects will be enrolled at up to two study sites in the United States. Safety and tolerability of BMT administration will be summarized and assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
Sterile aqueous solution for injection, provided as an autoinjector pen
8 mg tablet (over-encapsulation in a capsule)
capsule
ICON Early Phase Serrvices, LLC
San Antonio, Texas, United States
Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran.
Incidence of treatment-emergent nausea following a single dose of BMT 1.75 mg SC with or without concomitant use of Zofran.
Time frame: 2 Days
Severity of nausea using a Visual Analog Scale
"Severity of Nausea Visual Analog Scale", where the range is 0 to 100 and a lower value represents a better outcome
Time frame: 2 Days
Time to onset of nausea
The time to onset of nausea
Time frame: 2 Days
Duration of nausea
The duration of nausea
Time frame: 2 Days
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