Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses. This first-in-human and proof of concept study will consist of 4 parts, with Parts 1 and 2 in healthy volunteers and Parts 3 and 4 in cystic fibrosis patients.
Key facts
- Study ID
- NCT02190604
- Run by
- Novartis Pharmaceuticals
- People needed
- 153
- Starts
- 2012-07-31
- Expected to finish
- 2015-11-30
- Last updated by the study team
- 2020-12-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- Novartis Investigative Site — Birmingham, Alabama, United States
- Novartis Investigative Site — Denver, Colorado, United States
- Novartis Investigative Site — Chicago, Illinois, United States
- Novartis Investigative Site — Louisville, Kentucky, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — St Louis, Missouri, United States
- Novartis Investigative Site — Chapel Hill, North Carolina, United States
- Novartis Investigative Site — Columbus, Ohio, United States
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Ghent, Belgium
- Novartis Investigative Site — Montpellier, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Pierre-Bénite, France
- Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Dublin, Ireland
- Novartis Investigative Site — Bucharest, Romania
- Novartis Investigative Site — Livingston, West Lothian, United Kingdom
- Novartis Investigative Site — Belfast, United Kingdom
- Novartis Investigative Site — London, United Kingdom
- Novartis Investigative Site — Manchester, United Kingdom
- Novartis Investigative Site — Mid Glamorgan, United Kingdom
Full record on ClinicalTrials.gov
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