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Bioavailability of Tebipenem (SPR994) Crushed Tablet

NCT05296382 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-02-28

No results posted yet for this study

Summary

The purpose of this study is to measure the amount of the antibiotic, tebipenem (SPR994) that is bioavailable after crushing the tablet and administering through a feeding tube with and without tube feeds.

Conditions

  • Relative Bioavailability

Interventions

DRUG

Tebipenem tablet form

Tebipenem tablets will be administered intact or crushed

OTHER

Tube feeds

Tebipenem tablets will be administered with or without tube feeds

Sponsors & Collaborators

  • Spero Therapeutics

    collaborator INDUSTRY

  • Hartford Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-06-01
Completion
2022-12-23
FDA Drug
Yes

Countries

  • United States

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 NCT05296382 on ClinicalTrials.gov