A Safety and PK Study of IV Eravacycline
- Registration Number
- NCT03696550
- Lead Sponsor
- Tetraphase Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Eravacycline (TP-434) 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 Cohort 2 Eravacycline (TP-434) 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
- Primary Outcome Measures
Name Time Method Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance Screening (-2 to 1) to Day 7 CL, systemic clearance
Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution Screening (-2 to 1) to Day 7 Vd, volume of distribution
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration Screening (-2 to 1) to Day 7 Cmax, maximum observed plasma concentration
Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve Screening (-2 to 1) to Day 7 AUC0-t, area under the plasma concentration
Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose Screening (-2 to 1) to Day 7 AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life Screening (-2 to 1) to Day 7 t1/2, elimination half-life
Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration Screening (-2 to 1) to Day 7 Clast, last observed plasma concentration
Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time Screening (-2 to 1) to Day 7 AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
- Secondary Outcome Measures
Name Time Method Adverse Events From the time of signing the informed consent form to Day 7 Assess Adverse Events to assess safety and tolerability
Vital Signs including blood pressure Screening (-2 to 1) to Day 7 Changes in blood pressure
Vital Signs including respiratory rate Screening (-2 to 1) to Day 7 Changes in respiratory rate
Vital Signs including body temperature Screening (-2 to 1) to Day 7 Changes in body temperature
A Directed Physical examination including chest/respiratory Screening (-2 to 1) to Day 7. Changes in Physical examination findings including chest/respiratory
A Directed Physical examination including heart/cardiovascular Screening (-2 to 1) to Day 7. Changes in Physical examination findings including heart/cardiovascular
Vital Signs including heart rate Screening (-2 to 1) to Day 7 Changes in heart rate
Safety laboratory results including clinical chemistry Screening (-2 to 1) to Day 7 Changes in Clinical laboratory tests including clinical chemistry
Safety laboratory tests including hematology Screening (-2 to 1) to Day 7 Changes in Clinical laboratory tests including hematology
Trial Locations
- Locations (7)
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Ronald Reagan University of California Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States