Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Rifampin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

1. Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding.

2. Contraindication to receiving nilotinib or rifampin.

3. Smokers or use of tobacco products or products containing nicotine in the last 30 days

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 may apply.