Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00427505
Collaborator
(none)
22

Study Details

Study Description

Brief Summary

This is a study to investigate the pharmacokinetics of deferasirox

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers
Study Start Date :
Jul 1, 2006

Outcome Measures

Primary Outcome Measures

  1. To assess the effect of deferasirox on the pharmacokinetics of midazolam []

Secondary Outcome Measures

  1. Safety assessed by adverse events (AEs) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Good health

  • No evidence of iron deficiency

  • Weight between 50 and 100 kg

  • Body Mass Index between 19 and 29 kg/m2

Exclusion Criteria:
  • Use of certain drugs, herbal remedies or nutrients

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Novartis

Investigators

  • Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00427505
Other Study ID Numbers:
  • CICL670A2126
First Posted:
Jan 29, 2007
Last Update Posted:
Nov 19, 2009
Last Verified:
Nov 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2009