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

Condition(s) targeted: Healthy

Intervention: Deferasirox (Drug); Rifampicin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

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.

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 design: Treatment, Non-Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics Study

Primary outcome: Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox

Secondary outcome: Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion criteria

1. Able and willing to provide written informed consent prior to study participation

2. 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.

3. Able to communicate well with the investigator and comply with the requirements of the study

4. Subjects must have a body mass index (BMI) between 18 and 33.

5. Serum ferritin value ≥20 ng/mL and transferrin saturation (Iron/TIBC) ≥15% at screening

Exclusion criteria

1. History or presence of impaired renal function

2. Abnormal serum electrolytes (e. g. sodium, potassium, chloride, or bicarbonate), magnesium and calcium

3. Evidence of urinary obstruction or difficulty in voiding at screening

4. Anemia (defined as hemoglobin < 13 g/dL)

5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening

6. Subjects with a known history of HIV seropositivity or history of immunocompromise

7. A past medical history of any ECG abnormalities or a family history of a prolonged QT-interval syndrome

8. Donation or loss of 400 mL blood or more within 12 weeks prior to dosing

9. Smokers (use of tobacco products in the previous 3 months). * Other protocol-defined inclusion/exclusion criteria may apply

Starting date: January 2007
Last updated: July 5, 2007