NCT03376529

Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SPR741	400 mg IV over 1 hour
DRUG	Ceftazidime	1.0 gram IV over 1 hour
DRUG	Piperacillin/tazobactam	4.5 grams IV over 1 hour
DRUG	Aztreonam	1.0 gram IV over 1 hour

Timeline

• Start date: 2017-11-10
• Primary completion: 2017-12-19
• Completion: 2017-12-20
• First posted: 2017-12-18
• Last updated: 2018-01-05

Locations

1 site across 1 country: United Kingdom