Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cempra Inc; Melinta Therapeutics, Inc.
• Collaborator: Department of Health and Human Services
• Treatments: Solithromycin

Criteria

Inclusion Criteria:

• Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.

Exclusion Criteria:

• Serum creatinine >2 mg/dL

• Positive pregnancy test in females of childbearing potential

• History of intolerance or hypersensitivity to macrolide antibiotics