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NCT01966055 Clinical Trial

Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

Bacterial Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01966055
Other study ID # CE01-119
Secondary ID
Status Completed
Phase Phase 1
First received October 15, 2013
Last updated February 20, 2017
Start date December 2013
Est. completion date September 2014

Study information
Verified date February 2017
Source Cempra Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Solithromycin

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Cempra Inc Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents 5 days
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