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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00419172
First received: January 4, 2007
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Healthy
Drug: Deferasirox
Drug: Rifampicin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Estimated Enrollment: 22
Study Start Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419172

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00419172     History of Changes
Other Study ID Numbers: CICL670A2127
Study First Received: January 4, 2007
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Rifampin
Deferasirox
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Iron Chelating Agents
Chelating Agents
Sequestering Agents

ClinicalTrials.gov processed this record on September 18, 2014