Overview
Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteersPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
Inclusion1. 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