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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: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01769768 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 114 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pharmacokinetics of warfarin : Maximum observed plasma concentration after drug administration
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 |
What the finished NCT01769768 record still lists
NCT01769768 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 3 interventions - of which Bupropion is the first listed.
NCT01769768 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01769768's enrollment target sits among peer trials
114 507th of 2000 higher than 1,493 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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