Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Phase 1

Completed

• Conditions: Bacterial Infection
• Interventions: Drug: solithromycin

• Registration Number: NCT02268279
• Lead Sponsor: Melinta Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Study Start: 2015-01
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
solithromycin	solithromycin	oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents	5 to 7 days