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plerixafor

Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment

Ensayo de Sanofi en Insuficiencia renal.

Más ensayos de: Insuficiencia renal.

Fase

Fase 1

Estado

Completado

Participantes

23

previstos

Centros

3

Fin del objetivo primario

ago 2007

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2006.

Qué mide

Dose-Normalized Maximum Concentration of Plerixafor (Cmax) (Pre-dose of plerixafor to 24 hours post-plerixafor) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroEligible male and female subjects with renal impairment (aged 18-78 years) and healthy control subjects (aged 35 to 78 years) will be enrolled in the study. Subjects with renal impairment will be enrolled and entered into three groups based on their renal function: Mild Impairment, Moderate Impairment, and Severe Impairment(not requiring dialysis). Control subjects will have normal renal function. The screening visits will occur within 14 days prior to plerixafor administration on study day one. Subjects will be monitored for 10 hours following administration of the study drug. In addition, subjects will return to the clinic at 24 and 48 hours after plerixafor administration for blood samples and safety assessments.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00445302), actualizada en feb 2014.