Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
NCT ID: NCT01966055
Last Updated: 2017-02-23
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
13 participants
INTERVENTIONAL
2013-12-31
2014-09-30
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
Solithromycin
Interventions
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Solithromycin
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Clinical significant concomitant medical condition
12 Years
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
San Diego, California, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Ann Arbor, Michigan, United States
Hackensack, New Jersey, United States
New York, New York, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Galveston, Texas, United States
Houston, Texas, United States
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.
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.
Other Identifiers
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CE01-119
Identifier Type: -
Identifier Source: org_study_id
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