Trial record 6 of 701 for:    Open Studies | "Bacterial Infections"

Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

This study is currently recruiting participants.
Verified April 2014 by Cempra Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01966055
First received: October 15, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cempra Pharmaceuticals:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: December 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solithromycin Drug: Solithromycin

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01966055

Contacts
Contact: Connie Rosiak crosiak@cempra.com

Locations
United States, Arkansas
Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Recruiting
San Diego, California, United States, 92123
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States, 48109
United States, New York
Recruiting
New York, New York, United States, 10032
United States, Oregon
Recruiting
Portland, Oregon, United States, 97239
United States, Texas
Recruiting
Galveston, Texas, United States, 77555-0701
Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cempra Pharmaceuticals
Investigators
Principal Investigator: Michael Cohen-Wolkowiez, MD Duke Clinical Research Institute
  More Information

No publications provided

Responsible Party: Cempra Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01966055     History of Changes
Other Study ID Numbers: CE01-119
Study First Received: October 15, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014