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NCT01437384 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.
A Phase 1 study of Idiopathic Thrombocytopenic Purpura (ITP), sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01437384: Completed Phase 1 study of Idiopathic Thrombocytopenic Purpura (ITP), sponsored by Eisai.
NCT01437384 is a Phase 1 study of Idiopathic Thrombocytopenic Purpura (ITP) that has completed, run by Eisai. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437384, a Phase 1 study of Idiopathic Thrombocytopenic Purpura (ITP), has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. The treatment phase consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose; Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each treatment period. The screening period will be up to 13 days in duration. After fulfilling screening requirements, subjects will check into the clinic on Day -1 for baseline assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient visits. They will be domiciled in the clinical testing facility for at least 14 days for Treatment Period 2 and will return intermittently for study procedures for 7 outpatient visits.
Conditions Studied
Interventions
- DRUG E5501
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01437384 record still lists
NCT01437384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Idiopathic Thrombocytopenic Purpura (ITP) appearing as the primary indexed condition, and to 1 intervention - of which E5501 is the first listed.
NCT01437384 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01437384 about?
NCT01437384 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.". 36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. The treatment phase consists of 4 treatment peri...
What is the current status of trial NCT01437384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-09.
What conditions does trial NCT01437384 study?
This clinical trial studies the following conditions: Idiopathic Thrombocytopenic Purpura (ITP).
What interventions are being tested in trial NCT01437384?
The interventions under investigation include: E5501 (DRUG).
Who is sponsoring clinical trial NCT01437384?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01437384 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01437384's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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