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Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Primary Purpose

Bacterial Infection

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
solithromycin
Sponsored by
Melinta Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infection

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.

Exclusion Criteria:

  • Serum creatinine >2 mg/dL
  • Positive pregnancy test in females of childbearing potential
  • History of intolerance or hypersensitivity to macrolide antibiotics

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

solithromycin

Arm Description

oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents

Secondary Outcome Measures

Full Information

First Posted
October 15, 2014
Last Updated
June 7, 2017
Sponsor
Melinta Therapeutics, Inc.
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT02268279
Brief Title
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
Official Title
A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melinta Therapeutics, Inc.
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
solithromycin
Arm Type
Experimental
Arm Description
oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day
Intervention Type
Drug
Intervention Name(s)
solithromycin
Other Intervention Name(s)
CEM-101
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents
Time Frame
5 to 7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active. Exclusion Criteria: Serum creatinine >2 mg/dL Positive pregnancy test in females of childbearing potential History of intolerance or hypersensitivity to macrolide antibiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Cohen-Wolkowiez, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44103
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-3678
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Splendora
State/Province
Texas
ZIP/Postal Code
77372
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria

12. IPD Sharing Statement

Citations:
PubMed Identifier
31318840
Citation
Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670.
Results Reference
derived
PubMed Identifier
29891609
Citation
Gonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug.
Results Reference
derived

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Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

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