Trials / Completed
CompletedNCT02268279
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Melinta Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | solithromycin |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2014-10-20
- Last updated
- 2017-06-09
Locations
34 sites across 2 countries: United States, Bulgaria
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02268279. Inclusion in this directory is not an endorsement.