Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
Sponsor
Melinta Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01966055
Collaborator
Department of Health and Human Services (U.S. Fed)
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Study Details
Study Description
Brief Summary
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
13 participants
Allocation:
N/A
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
:
Dec 1, 2013
Actual Primary Completion Date
:
Aug 1, 2014
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Solithromycin
|
Drug: Solithromycin
|
Outcome Measures
Primary Outcome Measures
- Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents [5 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 17 Years
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Little Rock | Arkansas | United States | 72202 | |
| 2 | San Diego | California | United States | 92123 | |
| 3 | Chicago | Illinois | United States | 60611 | |
| 4 | Louisville | Kentucky | United States | 40202 | |
| 5 | Ann Arbor | Michigan | United States | 48109 | |
| 6 | Hackensack | New Jersey | United States | 07601 | |
| 7 | New York | New York | United States | 10032 | |
| 8 | Portland | Oregon | United States | 97239 | |
| 9 | Hershey | Pennsylvania | United States | 17033 | |
| 10 | Galveston | Texas | United States | 77555-0701 | |
| 11 | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Melinta Therapeutics, Inc.
- Department of Health and Human Services
Investigators
- Principal Investigator: Michael Cohen-Wolkowiez, MD, Duke Clinical Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01966055
Other Study ID Numbers:
- CE01-119
First Posted:
Oct 21, 2013
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017