This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
53
PRA Health Sciences - Early Development Services
Groningen, Netherlands
Part 1: Cmax
concentration time data
Time frame: 0-48 hours
Part 1: AUC0-inf
Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK
Time frame: 0-48 hours
Parts 2&3: Number of subjects with adverse events
Time frame: Day 15 (+2)
Part 1: Number of subjects with adverse events
Time frame: Day 14 (+2)
Parts 2&3: AUC0-tau
Time frame: Day 1
Parts 2&3: AUC0-tau
Time frame: Day 10
Parts 2&3: Cmax
Time frame: Day 1
Parts 2&3: Cmax
Time frame: Day 10
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