This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single oral dose
Single oral dose
ICON Plc.
Lenexa, Kansas, United States
Cmax
Maximum observed plasma concentration (Cmax)
Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
AUC0-t
Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t)
Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
AUC0-inf
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
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