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Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

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ClinicalTrials.gov Identifier: NCT01966055
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cempra Inc

Brief Summary:
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: Solithromycin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Solithromycin Drug: Solithromycin



Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Bacterial meningitis
  • Clinical significant concomitant medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966055


Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
San Diego, California, United States, 92123
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
New York, New York, United States, 10032
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, Texas
Galveston, Texas, United States, 77555-0701
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cempra Inc
Department of Health and Human Services
Investigators
Principal Investigator: Michael Cohen-Wolkowiez, MD Duke Clinical Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cempra Inc
ClinicalTrials.gov Identifier: NCT01966055     History of Changes
Other Study ID Numbers: CE01-119
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Infection
Bacterial Infections