Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
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
1 other identifier
interventional
13
1 country
11
Brief Summary
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2013
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 23, 2017
February 1, 2017
8 months
October 15, 2013
February 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents
5 days
Study Arms (1)
Solithromycin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- to 17 yo male or female with suspected or confirmed bacterial infection
You may not qualify if:
- Bacterial meningitis
- Clinical significant concomitant medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Galveston, Texas, 77555-0701, United States
Unknown Facility
Houston, Texas, 77030, United States
Related Publications (3)
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.
PMID: 31318840DERIVEDGonzalez 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.
PMID: 29891609DERIVEDGonzalez 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.
PMID: 26883693DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Cohen-Wolkowiez, MD
Duke Clinical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2013
First Posted
October 21, 2013
Study Start
December 1, 2013
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
February 23, 2017
Record last verified: 2017-02