Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

Nilotinib

Drug

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

Other names: AMN107A, Tasigna

Primary outcomes

To evaluate the effects of 600 mg rifampin on the pharmacokinetics (PK) of a single 400mg (2 x 200mg capsules) oral dose of AMN107

Time frame: at pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose after AMN107 administration on Days 1 and 16.

Secondary outcomes

To assess the safety and tolerability of a single 400mg (2x200mg capsules) oral dose of AMN107 given alone and concomitantly with 600mg rifampin
To determine the ratio of 6ß - hydroxylcortisol to cortisol in urine as an in-vivomarker of CYP3A4 induction with rifampin treatment4.

Time frame: on Days -1, 11, 15 and 19

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I Open-label, Two Period, Single Center Study to Assess 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

Important dates

Study start: 2006
Primary completion: 2006
First posted: Jan 5, 2007
Registry last updated: Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed