Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741
Status:
Completed
Trial end date:
2017-12-20
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Spero Therapeutics
Collaborators:
QPS Simbec Research
Treatments:
Aztreonam Ceftazidime Piperacillin Piperacillin, Tazobactam Drug Combination Tazobactam