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A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
NCT01579149 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01579149 reports 1 study location spanning 1 distinct geographic area — top geographies include Hawaii. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01579149?
The interventions under investigation include: Placebo (DRUG), plerixafor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01579149?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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