NCT00427505

Brief Summary

This is a study to investigate the pharmacokinetics of deferasirox

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

First QC Date

January 25, 2007

Last Update Submit

November 18, 2009

Conditions

Healthy

Keywords

Interactionhealthy volunteersdeferasiroxmidazolam

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of deferasirox on the pharmacokinetics of midazolam

Secondary Outcomes (1)

  • Safety assessed by adverse events (AEs)

Interventions

DeferasiroxDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good health
  • No evidence of iron deficiency
  • Weight between 50 and 100 kg
  • Body Mass Index between 19 and 29 kg/m2

You may not qualify if:

  • Use of certain drugs, herbal remedies or nutrients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Deferasirox

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

July 1, 2006

Last Updated

November 19, 2009

Record last verified: 2009-11