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

NCT00419172 | Completed Phase 1

• 1 other identifier: CICL670A2127
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Deferasirox; Exjade; ICL670; Rifampicin; Healthy, Volunteers

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox

Secondary Outcomes (1)

• Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox

Interventions

Deferasirox DRUG

Rifampicin DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Interventions

Deferasirox; Rifampin

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 8, 2007
• Study Start: January 1, 2007
• Last Updated: November 19, 2009

Record last verified: 2009-11