A Phase 1 Safety and PK Study of IV Eravacycline

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

December 13, 2018

Estimated Primary Completion Date

June 27, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration[ Time Frame: 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[ Time Frame: Screening (-2 to 1) to Day 7 ]

AUC0-t, area under the plasma concentration

Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time[ Time Frame: Screening (-2 to 1) to Day 7 ]

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

Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose[ Time Frame: 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[ Time Frame: Screening (-2 to 1) to Day 7 ]

t1/2, elimination half-life

Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration[ Time Frame: Screening (-2 to 1) to Day 7 ]

Clast, last observed plasma concentration

Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance[ Time Frame: Screening (-2 to 1) to Day 7 ]

CL, systemic clearance

Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution[ Time Frame: Screening (-2 to 1) to Day 7 ]

Vd, volume of distribution

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Adverse Events[ Time Frame: From the time of signing the informed consent form to Day 7 ]
Assess Adverse Events to assess safety and tolerability
A Directed Physical examination including chest/respiratory[ Time Frame: Screening (-2 to 1) to Day 7. ]
Changes in Physical examination findings including chest/respiratory
A Directed Physical examination including heart/cardiovascular[ Time Frame: Screening (-2 to 1) to Day 7. ]
Changes in Physical examination findings including heart/cardiovascular
Vital Signs including blood pressure[ Time Frame: Screening (-2 to 1) to Day 7 ]
Changes in blood pressure
Vital Signs including heart rate[ Time Frame: Screening (-2 to 1) to Day 7 ]
Changes in heart rate
Vital Signs including respiratory rate[ Time Frame: Screening (-2 to 1) to Day 7 ]
Changes in respiratory rate
Vital Signs including body temperature[ Time Frame: Screening (-2 to 1) to Day 7 ]
Changes in body temperature
Safety laboratory results including clinical chemistry[ Time Frame: Screening (-2 to 1) to Day 7 ]
Changes in Clinical laboratory tests including clinical chemistry
Safety laboratory tests including hematology[ Time Frame: Screening (-2 to 1) to Day 7 ]
Changes in Clinical laboratory tests including hematology

Descriptive Information

Brief Title ^ICMJE

A Phase 1 Safety and PK Study of IV Eravacycline

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single Group Assignment
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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)

Study Arms

Experimental: 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
Experimental: 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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 17, 2019

Estimated Primary Completion Date

June 27, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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. 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 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

8 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Tetraphase Pharmaceuticals, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名