Page Title
Clinical Trial Finder
Anti-Infective Closed to Enrollment
Study of Lefamulin in Adults with CF (Nabriva NAB-BC-3781-1014)
This study will look at the safety of and how the body processes lefamulin, a drug intended to treat infections in the lung. This study is for adults with CF.
This is an open label, randomized, crossover study. This means that all participants will receive the study drug and be randomized into Group A or Group B. Group A will receive one dose of intravenous lefamulin first, followed by one dose of oral lefamulin. Group B will receive one dose of oral lefamulin first, followed by one dose intravenous lefamulin.Researchers will study how the body processes the drug by measuring how much of the drug stays in the body. They will also evaluate safety. This study may require blood draws, questionnaires, and/or other measures.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Excludes use of Orkambi® (lumacaftor/ivacaftor) within 28 days prior to Day 1.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
13 days -
Number of Study Visits:
6
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
Nabriva Therapeutics -
Study Drugs:
Study Sites
-
Closed to Enrollment
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Boston, MA 02115
-
Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
-
Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
-
Closed to Enrollment
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
-
Closed to Enrollment
Utah
Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Excludes use of Orkambi® (lumacaftor/ivacaftor) within 28 days prior to Day 1.
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