NCT01579149

A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent

A Phase 1, Randomized, Single-center, Single-dose, Double-blind, Placebo-controlled Pharmacokinetic, Safety, and Pharmacodynamic Study of Subcutaneous Injection of 160 μg/kg, 240 μg/kg, and 400 μg/kg Plerixafor in Healthy Adult Volunteers of Japanese Descent

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	plerixafor	Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg),
DRUG	Placebo	Single subcutaneous (SC) dose of placebo

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-04-17
• Last updated: 2015-03-23

Locations

1 site across 1 country: United States