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

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ClinicalTrials.gov Identifier: NCT00419172
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:
Novartis

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox

Secondary Outcome Measures :
  1. Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419172


Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
More Information
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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00419172     History of Changes
Other Study ID Numbers: CICL670A2127
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

Keywords provided by Novartis:
Pharmacokinetics
Deferasirox
Exjade
 ICL670
Rifampicin
Healthy, Volunteers

Additional relevant MeSH terms:
Rifampin
Deferasirox
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Iron Chelating Agents
Chelating Agents
Sequestering Agents