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NCT01769768 · ClinicalTrials.gov registry record · Phase 1
Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
NCT01769768 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 114 participants.
The verdict
NCT01769768, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
Study Summary
This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.
Interventions
- DRUG Bupropion
- DRUG LDE225
- DRUG Wafarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01769768
The ClinicalTrials.gov registry entry for NCT01769768 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bupropion is the first listed.
NCT01769768 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01769768 about?
NCT01769768 is a clinical study titled "Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients". This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.
What is the current status of trial NCT01769768?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2013-04. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01769768?
The interventions under investigation include: Bupropion (DRUG), LDE225 (DRUG), Wafarin (DRUG).
Who is sponsoring clinical trial NCT01769768?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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