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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: Completed Phase 1 study of Healthy Volunteer, sponsored by Genzyme, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01579149 record still lists
NCT01579149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01579149's enrollment target sits among peer trials
24 85th of 112 higher than 20 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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