Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers - Full Text View

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 Endpoint Classification: Pharmacokinetics Study 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:

Drug Information available for: Rifampin Deferasirox

U.S. FDA Resources

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)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016