Trials / Completed
CompletedNCT01223898
To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib
An Open-label, Two-period, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics of Midazolam in CML Patients Who Are Resistant and/or Intolerant Against at Least One Prior Therapy With a BCR-ABL Tyrosine Kinase Inhibitor
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following extension study does evaluate the safety of nilotinib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tasigna |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2010-10-19
- Last updated
- 2020-12-09
Locations
5 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT01223898. Inclusion in this directory is not an endorsement.