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Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

This study has been completed.
Department of Health and Human Services
Information provided by (Responsible Party):
Cempra Inc Identifier:
First received: October 15, 2013
Last updated: February 20, 2017
Last verified: February 2017
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents

Condition Intervention Phase
Bacterial Infections Drug: Solithromycin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:

Further study details as provided by Cempra Inc:

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

Enrollment: 13
Study Start Date: December 2013
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solithromycin Drug: Solithromycin


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Bacterial meningitis
  • Clinical significant concomitant medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01966055

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
Principal Investigator: Michael Cohen-Wolkowiez, MD Duke Clinical Research Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cempra Inc Identifier: NCT01966055     History of Changes
Other Study ID Numbers: CE01-119
Study First Received: October 15, 2013
Last Updated: February 20, 2017

Additional relevant MeSH terms:
Bacterial Infections processed this record on June 22, 2017