Healthy Volunteers Clinical Trial
Official title:
A Single-center, Multi-arm, Open-label, Randomized, 3-period, Crossover, Phase 1 Study to Evaluate the DDI, PK, Safety, and Tolerability of Single Doses of SPR741 Co-administered With Three Different Antibiotics in Healthy Volunteers
This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3 different partner antibiotics, and the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate.
This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period crossover
study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a
single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime,
piperacillin/tazobactam, and aztreonam) in healthy volunteers. Participants will be
administered a single dose of SPR741 alone, a single dose of SPR741 in combination with 1 of
the 3 different partner antibiotics, and a single dose of the partner antibiotic alone in a
randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18
to 55 years of age are planned to participate in the study. Women of childbearing potential
will not be eligible to participate. The study will consist of 3 phases: a screening phase, a
treatment phase, and a follow-up phase.
The 3 treatment arms will be enrolled and dosed in parallel or in a staggered manner, as
needed for scheduling.
All participants in the study will be monitored for safety after administration of the last
dose of investigational product.
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