Status:
COMPLETED
Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00418769
Start Date
June 1 2006
Last Update
December 9 2020
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