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Effect of Tebipenem on Normal Human Intestinal Microbiota

NCT04376554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-04

No results posted yet for this study

Summary

The overall purpose of this study is to support the development of an oral formulation of TBPM-PI-HBr by assessing the potential ecological effects of tebipenem on the normal intestinal microbiota as compared to the effects of oral amoxicillin-clavulanate.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TBPM-PI-HBr

TBPM-PI-HBr (2 x 300mg tablets) PO q8h \[±1 hour\] for 10 days

DRUG

amoxicillin-clavulanate

amoxicillin-clavulanate (1 × 500mg/125mg tablet) PO q8h \[±1 hour\] for 10 days

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • Steffan Rosenborg · Karolinska Universitetssjukhuset

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2021-04-06
Completion
2021-04-06
FDA Drug
Yes

Countries

  • Sweden

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 NCT04376554 on ClinicalTrials.gov