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A Study to Compare Two Bioanalytical Assays for Tebipenem

NCT05856747 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-27

No results posted yet for this study

Summary

The primary purpose of the study is to compare the concentrations of tebipenem (TBP), the active moiety of tebipenem pivoxil hydrobromide (TBP-PI-HBr), as determined by two bioanalytical assays, a whole blood assay and a plasma assay, following a single oral dose of TBP-PI-HBr 600 milligram (mg) tablets in healthy adult participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TBP-PI-HBr

TBP-PI-HBr tablets.

Sponsors & Collaborators

  • Spero Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2023-06-01
Completion
2023-06-01
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 NCT05856747 on ClinicalTrials.gov