Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

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

Completed

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Bacterial meningitis
Clinical significant concomitant medical condition

Treatment and study plan

Solithromycin

Drug

Primary outcomes

Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents

Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Melinta Therapeutics, Inc.

Industry

Collaborators

Department of Health and Human Services

Registry information

Official study title

A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Oct 21, 2013
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed