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Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
This study has been completed.
Study NCT00419172   Information provided by Novartis
First Received: January 4, 2007   Last Updated: November 18, 2009   History of Changes

January 4, 2007
November 18, 2009
January 2007
 
Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox
Same as current
Complete list of historical versions of study NCT00419172 on ClinicalTrials.gov Archive Site
Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox
Same as current
 
Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
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

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics Study
Healthy
  • Drug: Deferasirox
  • Drug: Rifampicin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
22
 
 

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00419172
External Affairs, Novartis Pharmaceuticals
CICL670A2127
Novartis
 
Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP