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NCT01579149 · ClinicalTrials.gov registry record · Phase 1
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
A Phase 1 study of Healthy Volunteer, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01579149 is a Phase 1 study of Healthy Volunteer that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 24 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01579149, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG plerixafor
Study Locations (1)
Hawaii
- - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01579149
The ClinicalTrials.gov registry entry for NCT01579149 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (88% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01579149 reports 1 study location spanning 1 distinct geographic area - top geographies include Hawaii.
Frequently Asked Questions
What is clinical trial NCT01579149 about?
NCT01579149 is a clinical study titled "A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent". 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 w...
What is the current status of trial NCT01579149?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2012-02.
What conditions does trial NCT01579149 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01579149?
The interventions under investigation include: Placebo (DRUG), plerixafor (DRUG).
Who is sponsoring clinical trial NCT01579149?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01579149 being conducted?
This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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