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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

NCT04238195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-03-13

No results posted yet for this study

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.

Conditions

  • TQT Study

Interventions

DRUG

Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo

Treatment A: Subjects receive TBPM-PI-HBr + matching Placebo.

DRUG

Moxifloxacin 400mg

Treatment D: Subjects receive 1 400 mg tablet of moxifloxacin administered in an open label manner.

OTHER

Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)

Treatment C: Subjects receive TBPM-PI-HBr matching placebo.

DRUG

Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)

Treatment B: Subjects receive TBPM-PI-HBr.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Spero Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-01-19
Primary Completion
2020-02-26
Completion
2020-02-26
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 NCT04238195 on ClinicalTrials.gov