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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00418769

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Nilotinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nilotinib Tablet Formulations	Drug: Nilotinib
Active Comparator: Established Nilotinib Capsule Formulation	Drug: Nilotinib

Arm

Intervention/Treatment

Experimental: Nilotinib Tablet Formulations

Drug: Nilotinib

Active Comparator: Established Nilotinib Capsule Formulation

Drug: Nilotinib

Outcome Measures

Primary Outcome Measures

bioavailability of nilotinib []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion

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.
Laboratory parameter values must fall within the normal range

Exclusion

Female who is pregnant or breast feeding.
Contraindication to receiving nilotinib.
Smokers or user of tobacco products
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