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Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 1
Locations
United States
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 Infections

Eligibility Criteria

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

Inclusion Criteria:

  • 12 to 17 yo male or female with suspected or confirmed bacterial infection

Exclusion Criteria:

  • Bacterial meningitis
  • Clinical significant concomitant medical condition

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Solithromycin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2013
Last Updated
February 20, 2017
Sponsor
Melinta Therapeutics, Inc.
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01966055
Brief Title
Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
Official Title
A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Solithromycin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Solithromycin
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 12 to 17 yo male or female with suspected or confirmed bacterial infection Exclusion Criteria: Bacterial meningitis Clinical significant concomitant medical condition
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
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0701
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

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
PubMed Identifier
26883693
Citation
Gonzalez D, Palazzi DL, Bhattacharya-Mithal L, Al-Uzri A, James LP, Bradley J, Neu N, Jasion T, Hornik CP, Smith PB, Benjamin DK Jr, Keedy K, Fernandes P, Cohen-Wolkowiez M. Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2572-6. doi: 10.1128/AAC.02561-15. Print 2016 Apr.
Results Reference
derived

Learn more about this trial

Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

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