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Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00419172
First received: January 4, 2007
Last updated: November 18, 2009
Last verified: November 2009
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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 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 (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
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 Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419172
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419172
Sponsors and Collaborators
Novartis
Investigators
| Study Chair: | Novartis | Novartis |
More Information
| 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 |
Keywords provided by Novartis:
|
Pharmacokinetics Deferasirox Exjade |
ICL670 Rifampicin Healthy, Volunteers |
Additional relevant MeSH terms:
|
Deferasirox Rifampin Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents |
Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors 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 |
ClinicalTrials.gov processed this record on June 22, 2017