- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01966055
Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
February 20, 2017 updated by: Melinta Therapeutics, Inc.
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
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72202
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California
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San Diego, California, United States, 92123
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Illinois
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Chicago, Illinois, United States, 60611
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Kentucky
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Louisville, Kentucky, United States, 40202
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Michigan
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Ann Arbor, Michigan, United States, 48109
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New Jersey
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Hackensack, New Jersey, United States, 07601
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New York
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New York, New York, United States, 10032
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Oregon
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Portland, Oregon, United States, 97239
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
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Texas
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Galveston, Texas, United States, 77555-0701
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Houston, Texas, United States, 77030
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 12 to 17 yo male or female with suspected or confirmed bacterial infection
Exclusion Criteria:
- Bacterial meningitis
- Clinical significant concomitant medical condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Solithromycin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents
Time Frame: 5 days
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5 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ACTUAL)
August 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
October 15, 2013
First Submitted That Met QC Criteria
October 16, 2013
First Posted (ESTIMATE)
October 21, 2013
Study Record Updates
Last Update Posted (ACTUAL)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 20, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE01-119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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GlaxoSmithKlineCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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GlaxoSmithKlineCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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Clinical Trials on Solithromycin
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Melinta Therapeutics, Inc.CompletedUncomplicated Urogenital GonorrheaUnited States
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Melinta Therapeutics, Inc.Department of Health and Human ServicesCompletedBacterial InfectionUnited States, Bulgaria
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Melinta Therapeutics, Inc.CompletedNonalcoholic SteatohepatitisUnited States
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Melinta Therapeutics, Inc.National Institute of Allergy and Infectious Diseases (NIAID)CompletedUncomplicated Urogenital GonorrheaUnited States, Australia
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National Institute of Allergy and Infectious Diseases...Completed
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Imperial College LondonMelinta Therapeutics, Inc.TerminatedPulmonary Disease, Chronic ObstructiveUnited Kingdom
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Melinta Therapeutics, Inc.CompletedCommunity-acquired Bacterial PneumoniaSpain, United States, Hungary, Canada, Estonia, Russian Federation, Argentina, Bulgaria, Czech Republic, Dominican Republic, Ecuador, Germany, Latvia, Poland, Puerto Rico, Romania, South Africa
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Melinta Therapeutics, Inc.CompletedCommunity-acquired Bacterial PneumoniaSpain, United States, Philippines, Taiwan, Canada, Germany, Poland, Russian Federation, Argentina, Bulgaria, South Africa, Slovenia, Serbia, Colombia, Hungary, Netherlands, Slovakia, Ukraine, Peru, Latvia, Guatemala, Romania, Chile, G... and more
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Melinta Therapeutics, Inc.CompletedCommunity-Acquired Bacterial PneumoniaUnited States, Canada
-
Melinta Therapeutics, Inc.Biomedical Advanced Research and Development AuthorityTerminatedCommunity-acquired Bacterial PneumoniaSpain, United States, Philippines, Hungary, United Kingdom, Bulgaria