A Safety and PK Study of IV Eravacycline

Bacterial Infections Clinical Trial

Official title:

A Phase 1, Open-label, Multicenter Study to Determine the Pharmacokinetics and Safety of Intravenous Eravacycline in Children With Suspected or Confirmed Bacterial Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696550
• Other study ID #: TP-434-028
• Status: Completed
• Phase: Phase 1
• Start date: December 20, 2018
• Est. completion date: March 19, 2021

Study information

• Verified date: December 2021
• Source: La Jolla Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 19, 2021
• Est. primary completion date: March 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infections

Intervention

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)

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Lurie Children's Hospital	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Ronald Reagan University of California Los Angeles Medical Center	Los Angeles	California
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tetraphase Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration	Cmax, maximum observed plasma concentration	Screening (-2 to 1) to Day 7
Primary	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
Primary	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
Primary	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
Primary	Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life	t1/2, elimination half-life	Screening (-2 to 1) to Day 7
Primary	Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration	Clast, last observed plasma concentration	Screening (-2 to 1) to Day 7
Primary	Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance	CL, systemic clearance	Screening (-2 to 1) to Day 7
Primary	Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution	Vd, volume of distribution	Screening (-2 to 1) to Day 7
Secondary	Adverse Events	Assess Adverse Events to assess safety and tolerability	From the time of signing the informed consent form to Day 7
Secondary	A Directed Physical examination including chest/respiratory	Changes in Physical examination findings including chest/respiratory	Screening (-2 to 1) to Day 7.
Secondary	A Directed Physical examination including heart/cardiovascular	Changes in Physical examination findings including heart/cardiovascular	Screening (-2 to 1) to Day 7.
Secondary	Vital Signs including blood pressure	Changes in blood pressure	Screening (-2 to 1) to Day 7
Secondary	Vital Signs including heart rate	Changes in heart rate	Screening (-2 to 1) to Day 7
Secondary	Vital Signs including respiratory rate	Changes in respiratory rate	Screening (-2 to 1) to Day 7
Secondary	Vital Signs including body temperature	Changes in body temperature	Screening (-2 to 1) to Day 7
Secondary	Safety laboratory results including clinical chemistry	Changes in Clinical laboratory tests including clinical chemistry	Screening (-2 to 1) to Day 7
Secondary	Safety laboratory tests including hematology	Changes in Clinical laboratory tests including hematology	Screening (-2 to 1) to Day 7