Clinical trial NCT03696550: A Safety and PK Study of IV Eravacycline
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Lead sponsor: La Jolla Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration
timeFrame: Screening (-2 to 1) to Day 7
measure: Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve
timeFrame: Screening (-2 to 1) to Day 7
measure: Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
timeFrame: Screening (-2 to 1) to Day 7
measure: Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
timeFrame: Screening (-2 to 1) to Day 7
measure: Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life
timeFrame: Screening (-2 to 1) to Day 7
measure: Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration
timeFrame: Screening (-2 to 1) to Day 7
measure: Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance
timeFrame: Screening (-2 to 1) to Day 7
measure: Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution
timeFrame: Screening (-2 to 1) to Day 7
Secondary outcomes:
measure: Adverse Events
timeFrame: From the time of signing the informed consent form to Day 7
measure: A Directed Physical examination including chest/respiratory
timeFrame: Screening (-2 to 1) to Day 7.
measure: A Directed Physical examination including heart/cardiovascular
timeFrame: Screening (-2 to 1) to Day 7.
measure: Vital Signs including blood pressure
timeFrame: Screening (-2 to 1) to Day 7
measure: Vital Signs including heart rate
timeFrame: Screening (-2 to 1) to Day 7
measure: Vital Signs including respiratory rate
timeFrame: Screening (-2 to 1) to Day 7
measure: Vital Signs including body temperature
timeFrame: Screening (-2 to 1) to Day 7
measure: Safety laboratory results including clinical chemistry
timeFrame: Screening (-2 to 1) to Day 7
measure: Safety laboratory tests including hematology
timeFrame: Screening (-2 to 1) to Day 7
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan University of California Los Angeles Medical Center
state: California
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital
state: Ohio
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
References: