This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00419172

Sponsors and Collaborators
Study Chair: Novartis Novartis
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00419172     History of Changes
Other Study ID Numbers: CICL670A2127
Study First Received: January 4, 2007
Last Updated: November 18, 2009

Keywords provided by Novartis:
Healthy, Volunteers

Additional relevant MeSH terms:
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 processed this record on August 18, 2017