Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
Eligible 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.