NCT00418769

Brief Summary

Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
5 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

December 9, 2020

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

January 3, 2007

Last Update Submit

December 6, 2020

Conditions

Healthy

Keywords

nilotinibbioavailabilitytabletcapsulePKhealthy, subject(s),

Outcome Measures

Primary Outcomes (1)

  • bioavailability of nilotinib

Study Arms (2)

Nilotinib Tablet Formulations

EXPERIMENTAL
Drug: Nilotinib

Established Nilotinib Capsule Formulation

ACTIVE COMPARATOR
Drug: Nilotinib

Interventions

NilotinibDRUG
Established Nilotinib Capsule FormulationNilotinib Tablet Formulations

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
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.
  • Laboratory parameter values must fall within the normal range

You may not qualify if:

  • Female who is pregnant or breast feeding.
  • Contraindication to receiving nilotinib.
  • Smokers or user of tobacco products
  • 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

Related Links

MeSH Terms

Interventions

nilotinib

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 5, 2007

Study Start

June 1, 2006

Primary Completion

August 1, 2006

Last Updated

December 9, 2020

Record last verified: 2012-04