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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00419172

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Deferasirox Drug: Rifampicin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

A Phase I, Single Center, Open-label, One-sequence Cross-over Study to Investigate the Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers

Study Start Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox []

Secondary Outcome Measures

Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion criteria

Able and willing to provide written informed consent prior to study participation
Male subjects from 18 - 45 years of age in good health and no evidence of iron deficiency. Subjects of reproductive potential must use barrier contraception throughout the trial.
Able to communicate well with the investigator and comply with the requirements of the study
Subjects must have a body mass index (BMI) between 18 and 33.
Serum ferritin value ≥20 ng/mL and transferrin saturation (Iron/TIBC) ≥15% at screening

Exclusion criteria

History or presence of impaired renal function
Abnormal serum electrolytes (e.g. sodium, potassium, chloride, or bicarbonate), magnesium and calcium
Evidence of urinary obstruction or difficulty in voiding at screening
Anemia (defined as hemoglobin < 13 g/dL)
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening
Subjects with a known history of HIV seropositivity or history of immunocompromise
A past medical history of any ECG abnormalities or a family history of a prolonged QT-interval syndrome
Donation or loss of 400 mL blood or more within 12 weeks prior to dosing
Smokers (use of tobacco products in the previous 3 months). * Other protocol-defined inclusion/exclusion criteria may apply