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NCT02253420 · ClinicalTrials.gov registry record · Phase 1
COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02253420 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 51 participants.
The verdict
NCT02253420, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946). To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.
Interventions
- DRUG Rifampin
- DRUG Itraconazole
- DRUG Copanlisib (BAY80-6946)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-10-08 |
| Est. Completion | 2019-08-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02253420
The ClinicalTrials.gov registry entry for NCT02253420 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rifampin is the first listed.
NCT02253420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02253420 about?
NCT02253420 is a clinical study titled "COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients". To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946). To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.
What is the current status of trial NCT02253420?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2014-10-08. Estimated completion is 2019-08-13.
What interventions are being tested in trial NCT02253420?
The interventions under investigation include: Rifampin (DRUG), Itraconazole (DRUG), Copanlisib (BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT02253420?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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