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

Patrocinadores

Patrocinador principal: Novartis

Fuente Novartis
Resumen breve

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.

Estado general Completed
Fecha de inicio January 2007
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox
Resultado secundario
Medida Periodo de tiempo
Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox
Inscripción 22
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Deferasirox

Tipo de intervención: Drug

Nombre de intervención: Rifampicin

Elegibilidad

Criterios:

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

Género: Male

Edad mínima: 18 Years

Edad máxima: 45 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Novartis Study Chair Novartis
Fecha de verificación

November 2009

Fiesta responsable

Nombre Titulo: External Affairs

Organización: Novartis Pharmaceuticals

Palabras clave
Tiene acceso ampliado No
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Treatment

Enmascaramiento: Single

Fuente: ClinicalTrials.gov