Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Melinta Therapeutics

Status and phase: Completed; Phase 1

Conditions: Bacterial Infection

Treatments: Drug: solithromycin

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02268279

CE01-120

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

solithromycin

Experimental group

Description:

oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day

Treatment:

Drug: solithromycin