Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
NCT ID: NCT02268279
Last Updated: 2017-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2015-01-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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solithromycin
oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day
solithromycin
Interventions
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solithromycin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Positive pregnancy test in females of childbearing potential
* History of intolerance or hypersensitivity to macrolide antibiotics
17 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
Melinta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Cohen-Wolkowiez, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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Little Rock, Arkansas, United States
Orange, California, United States
Palo Alto, California, United States
San Diego, California, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Splendora, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Countries
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References
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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.
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.
Other Identifiers
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CE01-120
Identifier Type: -
Identifier Source: org_study_id
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