NCT00418756

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
Last Updated

March 19, 2010

Status Verified

March 1, 2010

Enrollment Period

1 month

First QC Date

January 3, 2007

Last Update Submit

March 18, 2010

Conditions

Healthy

Keywords

nilotinibRifampinPKhealthy subjects

Outcome Measures

Primary Outcomes (1)

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

    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 (2)

  • 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.

    on Days -1, 11, 15 and 19

Study Arms (1)

Rifampin + nilotinib

EXPERIMENTAL
Drug: Nilotinib

Interventions

NilotinibDRUG

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

Also known as: AMN107A, Tasigna
Rifampin + nilotinib

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

nilotinib

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 5, 2007

Study Start

October 1, 2006

Primary Completion

November 1, 2006

Last Updated

March 19, 2010

Record last verified: 2010-03