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Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00418756
First received: January 3, 2007
Last updated: March 18, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Nilotinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of a single 400mg (2x200mg capsules) oral dose of AMN107 given alone and concomitantly with 600mg rifampin [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418756

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00418756     History of Changes
Other Study ID Numbers: CAMN107A2115
Study First Received: January 3, 2007
Last Updated: March 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
nilotinib
Rifampin
PK
healthy subjects

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013