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

NCT03376529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-01-05

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • QPS Holdings LLC

    collaborator INDUSTRY

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • Annelize Koch, MBChB · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-10
Primary Completion
2017-12-19
Completion
2017-12-20

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376529 on ClinicalTrials.gov