Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

Phase 1

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: Solithromycin

• Registration Number: NCT01966055
• Lead Sponsor: Melinta Therapeutics, Inc.

Brief Summary

A study of the safety and pharmacokinetics of solithromycin capsules in adolescents

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-21
• Study Start: 2013-12
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 12 to 17 yo male or female with suspected or confirmed bacterial infection

Exclusion Criteria

• Bacterial meningitis
• Clinical significant concomitant medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solithromycin	Solithromycin	-

Primary Outcome Measures

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