Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects
- Registration Number
- NCT00418756
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects:
- Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33.
Exclusion Criteria
- Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding.
- Contraindication to receiving nilotinib or rifampin.
- Smokers or use of tobacco products or products containing nicotine in the last 30 days
- A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.
Other protocol-defined inclusion/exclusion may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rifampin + nilotinib Nilotinib -
- Primary Outcome Measures
Name Time Method To evaluate the effects of 600 mg rifampin on the pharmacokinetics (PK) of a single 400mg (2 x 200mg capsules) oral dose of AMN107 at pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose after AMN107 administration on Days 1 and 16.
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of a single 400mg (2x200mg capsules) oral dose of AMN107 given alone and concomitantly with 600mg rifampin To determine the ratio of 6ß - hydroxylcortisol to cortisol in urine as an in-vivomarker of CYP3A4 induction with rifampin treatment4. on Days -1, 11, 15 and 19