Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rifampin + nilotinib

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Semi-synthetic antibiotic derivative of rifamycin B and is known to induce cytochrome P-450 (CYP) enzymes.

Interventions

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Nilotinib

Semi-synthetic antibiotic derivative of rifamycin B and is known to induce cytochrome P-450 (CYP) enzymes.

Intervention Type DRUG

Other Intervention Names

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AMN107A, Tasigna

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes