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

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418769

CAMN107A2117

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Nilotinib Tablet Formulations

Experimental group

Treatment:

Drug: Nilotinib

Established Nilotinib Capsule Formulation

Active Comparator group

Treatment:

Drug: Nilotinib