Overview

A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects

Status:
Completed

Trial end date:
2020-02-26

Target enrollment:

Participant gender:

Summary

This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide [TBPM-PI-HBr]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. There will be a washout period of at least 7 days between dosing in each period and each subject will receive all 4 treatments over 4 periods in a crossover study design.

Phase:

Phase 1

Details

Lead Sponsor:

Spero Therapeutics

Collaborator:

Celerion

Treatments:

Moxifloxacin
Norgestimate, ethinyl estradiol drug combination