Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418756
Recruitment Status : Completed
First Posted : January 5, 2007
Last Update Posted : March 19, 2010
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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

Condition or disease Intervention/treatment Phase
Healthy Drug: Nilotinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-label, Two Period, Single Center Study to Assess 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
Study Start Date : October 2006
Actual Primary Completion Date : November 2006

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rifampin + nilotinib Drug: Nilotinib
Semi-synthetic antibiotic derivative of rifamycin B and is known to induce cytochrome P-450 (CYP) enzymes.
Other Name: AMN107A, Tasigna

Primary Outcome Measures :
  1. To evaluate the effects of 600 mg rifampin on the pharmacokinetics (PK) of a single 400mg (2 x 200mg capsules) oral dose of AMN107 [ Time Frame: 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 :
  1. To assess the safety and tolerability of a single 400mg (2x200mg capsules) oral dose of AMN107 given alone and concomitantly with 600mg rifampin
  2. To determine the ratio of 6ß - hydroxylcortisol to cortisol in urine as an in-vivomarker of CYP3A4 induction with rifampin treatment4. [ Time Frame: on Days -1, 11, 15 and 19 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects:
  2. Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33.

Exclusion Criteria:

  1. Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding.
  2. Contraindication to receiving nilotinib or rifampin.
  3. Smokers or use of tobacco products or products containing nicotine in the last 30 days
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418756

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00418756     History of Changes
Other Study ID Numbers: CAMN107A2115
First Posted: January 5, 2007    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: March 2010

Keywords provided by Novartis:
healthy subjects

Additional relevant MeSH terms:
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers