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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Deferasirox Drug: Rifampicin | Phase 1 |
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 |
- Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox
- Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
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

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
Study Chair: | Novartis | Novartis |
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 |