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The primary objective is to assess the pharmacokinetics of 3 dose levels of plerixafor injection (160 μg/kg, 240 μg/kg, and 400 μg/kg) in healthy adult subjects of Japanese descent. Three cohorts of subjects will be enrolled. Approximately 8 subjects will be enrolled in each cohort, 6 subjects who will receive a single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), and 2 subjects who will receive a single SC dose of placebo. The lowest dose-level cohort (plerixafor 160 μg/kg) will be fully enrolled first, followed by the next highest dose-level cohort (plerixafor 240 μg/kg), and finally the highest dose-level cohort (plerixafor 400 μg/kg), provided safety criteria for dose escalation are met.
Screening will occur within 28 days prior to dosing. Dosing will occur on Day 1 of each cohort. Subjects will remain at the study center from Day -1 until discharge approximately 24 hours after dosing (Day 2) for pharmacokinetic, safety, and pharmacodynamic assessments; however, all subjects who receive any investigational product, including any subjects who prematurely withdraw from the study, will remain at the study center for a minimum of 4 hours after dosing. A 15-day follow-up visit will be conducted 15 to 20 days postdose. The study will be considered completed for a subject at the time he/she completes the 15-day follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plerixafor | Experimental | Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plerixafor | Drug | Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics as measured by maximum observed concentration (Cmax) | Pre-dose to 24 hours post-dose | |
| Pharmacokinetics as measured by time to maximum concentration (Tmax) | Pre-dose to 24 hours post-dose | |
| • Pharmacokinetics as measured by area under the concentration-time curve (AUC) from Time 0 to 24 hours post-dose | Pre-dose to 24 hours post-dose | |
| Pharmacokinetics as measured by terminal half-life (t1/2) | Pre-dose to 24 hours post-dose | |
| Pharmacokinetics as measured by apparent volume of distribution (Vz/F) | Pre-dose to 24 hours post-dose | |
| Pharmacokinetics as measured by apparent total systemic clearance (CL/F) | Pre-dose to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) | From the administration of study drug and up to 15 day follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honolulu | Hawaii | United States |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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| Placebo | Drug | Single subcutaneous (SC) dose of placebo |
|