Trial intelligence / Profile preview

PK and Safety of Tebipenem HBr in Subjects with Renal Impairment

NCT04178577Phase 1Completed

Sponsor
Spero Therapeutics
Start
Dec 2019
Primary completion
Sep 2020
Modality
Drug Delivery Systems
Countries
1
01

Overview

Phase 1, open-label, single-arm trial of tebipenem in complicated urinary tract infection (cUTI) and acute pyelonephritis, sponsored by Spero Therapeutics. Primary endpoints: Apparent total body clearance, Area under the curve from time zero to the last quantifiable sample and 5 more. Started Dec 2019; status: completed.

02

Drugs

tebipenem
03

Conditions

complicated urinary tract infection (cUTI)acute pyelonephritis

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