Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
NCT02268279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2017-06-09
Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Conditions
Interventions
- DRUG
-
solithromycin
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
Melinta Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Michael Cohen-Wolkowiez, MD · Duke Clinical Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2016-10-31
- Completion
- 2016-10-31
- FDA Drug
- Yes
Countries
- United States
- Bulgaria
Study Locations
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