Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418756

CAMN107A2115

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Rifampin + nilotinib

Experimental group

Treatment:

Drug: Nilotinib