A Safety and PK Study of IV Eravacycline

NCT ID: NCT03696550

Last Updated: 2021-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2021-03-19

Brief 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.

Detailed Description

This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of IV eravacycline in children with suspected or confirmed bacterial infection who are receiving systemic antibiotic therapy, other than eravacycline. The study design will allow for evaluation of PK and safety of IV eravacycline in a pediatric population at exposures predicted to be comparable to those already studied in adults. The study design is depicted in Figure 1.

Two cohorts defined by age group will be enrolled simultaneously:

• Cohort 1: 12 to <18 years of age (adolescents)
• Cohort 2: 8 to <12 years of age (younger children) Eravacycline will be administered as a single IV dose using the optimum dosage determined from PK-PD modeling and model-based simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK analysis at predetermined timepoints.

Conditions

Bacterial Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Eravacycline (TP-434) intravenous formulation Eravacycline will be administered as a single 60 minute IV infusion according to age.

Age group (years) Dose (mg/kg) 12 to <18 (Cohort 1) 1.50

Group Type: EXPERIMENTAL

Eravacycline (TP-434)

Intervention Type: DRUG

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)

Cohort 2

Eravacycline will be administered as a single 60 minute IV infusion according to age.

Age group (years) Dose (mg/kg) 8 to <12 (Cohort 2) 1.75

Group Type: EXPERIMENTAL

Eravacycline (TP-434)

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Trade name: Xerava™

Eligibility Criteria

Inclusion Criteria

1. Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained

2. Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements)

3. Hospitalized, in stable condition, and receiving or plan to receive within 24 hours systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed bacterial infection

4. Likely to survive the current illness

5. In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug

6. The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug

Exclusion Criteria

1. Evidence or history of a clinically significant medical condition that may, in the assessment of the Investigator, impair study participation or pose a significant safety risk or diminish the subject's ability to undergo all study procedures and assessments

2. Received an investigational product and/or device within 30 days prior to study drug administration or is currently enrolled in any other clinical study involving an investigational product or any other type of medical treatment judged by the Investigator, in consultation with the Medical Monitor, not to be scientifically or medically compatible with this study

3. History of hypersensitivity to tetracycline antibiotics

4. Prior dosing in this protocol

5. Unlikely to survive at least 48 hours following administration of study drug

6. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol

7. Subject is a child of an employee of the Investigator or study center who has direct involvement in the proposed study or other studies under the direction of the same Investigator or study center, or an immediate family member of the employee or the Investigator, defined as a spouse, parent, child, or sibling, whether biological or legally adopted

8. Breastfeeding females

9. Females of childbearing potential [those with menarche and/or thelarche (beginning of breast development)] and sexually active males who are unwilling or unable to use an acceptable method of contraception

10. Positive pregnancy test in females of childbearing potential

11. Any other circumstance that, in the opinion of the Investigator, would preclude subject participation in the study

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tetraphase Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, United States

Lurie Children's Hospital

Chicago, Illinois, United States

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

TP-434-028

Identifier Type: -

Identifier Source: org_study_id