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NCT01582399 · ClinicalTrials.gov registry record · Phase 1
Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01582399: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT01582399 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01582399, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP1240. In addition, the study will determine the effects of ASKP1240 on the body by looking at its pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as SC injection.
Primary Outcome
Area under the serum concentration- time curve from time 0 up to the last quantifiable concentration (AUClast), Area under the serum concentration- time curve from time 0 extrapolated to infinity (AUCinf), and Absolute bioavailability (F)
Interventions
- DRUG ASKP1240
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01582399 record still lists
NCT01582399 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which ASKP1240 is the first listed.
NCT01582399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01582399 about?
NCT01582399 is a clinical study titled "Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240". The objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP124...
What is the current status of trial NCT01582399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-02. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01582399?
The interventions under investigation include: ASKP1240 (DRUG).
Who is sponsoring clinical trial NCT01582399?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01582399's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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