Status:
COMPLETED
Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects
Eligibility Criteria
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.
Exclusion
- Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding.
- Contraindication to receiving nilotinib or rifampin.
- Smokers or use of tobacco products or products containing nicotine in the last 30 days
- A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.
- Other protocol-defined inclusion/exclusion may apply.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00418756
Start Date
October 1 2006
Last Update
March 19 2010
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