Status:
COMPLETED
Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
Lead Sponsor:
Novartis
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 pe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00419172
Start Date
January 1 2007
Last Update
November 19 2009
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