A Safety and PK Study of IV Eravacycline

NCT03696550 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TP-434-028
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (8)

• Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration

  Cmax, maximum observed plasma concentration

  Screening (-2 to 1) to Day 7

• Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve

  AUC0-t, area under the plasma concentration

  Screening (-2 to 1) to Day 7

• Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time

  AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time

  Screening (-2 to 1) to Day 7

• Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose

  AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose

  Screening (-2 to 1) to Day 7

• Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life

  t1/2, elimination half-life

  Screening (-2 to 1) to Day 7

• Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration

  Clast, last observed plasma concentration

  Screening (-2 to 1) to Day 7

• Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance

  CL, systemic clearance

  Screening (-2 to 1) to Day 7

• Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution

  Vd, volume of distribution

  Screening (-2 to 1) to Day 7

Secondary Outcomes (9)

• Adverse Events

  From the time of signing the informed consent form to Day 7

• A Directed Physical examination including chest/respiratory

  Screening (-2 to 1) to Day 7.

• A Directed Physical examination including heart/cardiovascular

  Screening (-2 to 1) to Day 7.

• Vital Signs including blood pressure

  Screening (-2 to 1) to Day 7

• Vital Signs including heart rate

  Screening (-2 to 1) to Day 7

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: Eravacycline (TP-434)

Cohort 2

EXPERIMENTAL

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

Drug: Eravacycline (TP-434)

Interventions

Eravacycline (TP-434) 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)

Also known as: Trade name: Xerava™

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female from 8 to \<18 years of age on the day informed consent (and assent, if applicable) is obtained
• Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements)
• 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
• Likely to survive the current illness
• In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug
• The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug

You may not qualify if:

• 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
• 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
• History of hypersensitivity to tetracycline antibiotics
• Prior dosing in this protocol
• Unlikely to survive at least 48 hours following administration of study drug
• Unable or unwilling, in the judgment of the Investigator, to comply with the protocol
• 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
• Breastfeeding females
• 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
• Positive pregnancy test in females of childbearing potential
• Any other circumstance that, in the opinion of the Investigator, would preclude subject participation in the study

Sponsors & Collaborators

• Tetraphase Pharmaceuticals, Inc: lead

Study Sites (7)

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

eravacycline

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 4, 2018
• Study Start: December 20, 2018
• Primary Completion: March 14, 2021
• Study Completion: March 19, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

US (7)