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A Safety and PK Study of IV Eravacycline

NCT03696550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-12-03

No results posted yet for this study

Summary

This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection. Male and Female subjects from 8 to \<18 years of age who fulfill the inclusion/exclusion criteria will be enrolled in this study.

Conditions

Interventions

DRUG

Eravacycline (TP-434)

Subjects will be stratified by age into 2 cohorts, as follows: * Cohort 1: from 12 to \<18 years of age (N=8) * Cohort 2: from 8 to \<12 years of age (N=12 or at least 60% of subjects)

Sponsors & Collaborators

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2021-03-14
Completion
2021-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03696550 on ClinicalTrials.gov