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

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

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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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
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