Overview

Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete both treatment periods as per protocol. For all subjects, in addition to the two treatment periods, there will be a 21 day screening period, one baseline evaluation (the day preceding deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS). Study subjects will be required to remain in the unit from Day -1 until Day 17. EOS evaluation (final safety assessment) will be performed 7-10 days after the last dose of rifampicin.
Phase:
Phase 1
Details
Lead Sponsor:
Novartis
Treatments:
Deferasirox
Rifampin