Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00418769
First received: January 3, 2007
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers


Condition Intervention Phase
Healthy
Drug: Nilotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Two-arm, Three Period Crossover Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • bioavailability of nilotinib [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Tablet Formulations Drug: Nilotinib
Active Comparator: Established Nilotinib Capsule Formulation Drug: Nilotinib

  Eligibility

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

Inclusion

  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.
  3. Laboratory parameter values must fall within the normal range

Exclusion

  1. Female who is pregnant or breast feeding.
  2. Contraindication to receiving nilotinib.
  3. Smokers or user of tobacco products
  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 criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418769

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00418769     History of Changes
Other Study ID Numbers: CAMN107A2117
Study First Received: January 3, 2007
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
nilotinib
bioavailability
tablet
capsule
PK
healthy, subject(s),

ClinicalTrials.gov processed this record on July 23, 2014