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NCT01408394 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam
A Phase 1 study of Healthy, sponsored by Emalex Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01408394: Completed Phase 1 study of Healthy, sponsored by Emalex Biosciences.
NCT01408394 is a Phase 1 study of Healthy that has completed, run by Emalex Biosciences. The registered enrollment target is 16 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408394, a Phase 1 study of Healthy, has completed, sponsored by Emalex Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible diseases. To date, all clinical studies have been done using the ecopipam immediate release (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been produced that may be able to improve its effectiveness and reduce its side effects. The main purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when given as single oral dose in healthy volunteers.
Primary Outcome
Physical examinations, adverse events, vital signs, clinical laboratory values, ECG and Columbia Suicide Severity Ratings scale
Conditions Studied
Interventions
- DRUG Ecopipam immediate release form
- DRUG 90 mg controlled release form
- DRUG 180 mg controlled release form
Study Locations (1)
Maryland
- SNBL Clinical Pharmacology Center, Inc. - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01408394 record still lists
NCT01408394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Ecopipam immediate release form is the first listed.
NCT01408394 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01408394 about?
NCT01408394 is a clinical study titled "Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam". Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible diseases. To date, all clinical studies have been done using the ecopipam immediate release (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been produced that may be able to...
What is the current status of trial NCT01408394?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2011-08. Estimated completion is 2012-05.
What conditions does trial NCT01408394 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01408394?
The interventions under investigation include: Ecopipam immediate release form (DRUG), 90 mg controlled release form (DRUG), 180 mg controlled release form (DRUG).
Who is sponsoring clinical trial NCT01408394?
This trial is sponsored by Emalex Biosciences, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01408394 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT01408394's enrollment target sits among peer trials
16 936th of 1090 higher than 137 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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