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NCT01774747 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Oral Dose Evaluation of the Safety, Tolerability, and Pharmacokinetics of DSP-1053 and Its Metabolites in Healthy Subjects and in Subjects With Major Depressive Disorder
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT01774747: Clinical Trial Phase 1 study, sponsored by Sumitomo Pharma America.
NCT01774747 is a Phase 1 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01774747, a Phase 1 study, was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
Double-blind, placebo-controlled, multiple ascending oral dose evaluation of the safety, tolerability, and pharmacokinetics of DSP 1053 and its metabolites in healthy subjects and in subjects with major depressive disorder
Primary Outcome
* At least 50% of subjects within a cohort at dose level experience multiple moderate drug related adverse events or one severe drug-related adverse event * one drug related serious adverse event within a cohort at dose level * seizure of any severity or seriousness is observed in a subject who received DSP-1053 * Mean plasma DSR\_22898 Cmax greater or equal to 32ng/ml for a cohort
Interventions
- DRUG Placebo
- DRUG DSP-1053
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
Why NCT01774747 stopped before completion
NCT01774747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01774747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01774747 about?
NCT01774747 is a clinical study titled "A Multiple Ascending Oral Dose Evaluation of the Safety, Tolerability, and Pharmacokinetics of DSP-1053 and Its Metabolites in Healthy Subjects and in Subjects With Major Depressive Disorder". Double-blind, placebo-controlled, multiple ascending oral dose evaluation of the safety, tolerability, and pharmacokinetics of DSP 1053 and its metabolites in healthy subjects and in subjects with major depressive disorder
What is the current status of trial NCT01774747?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2012-12. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01774747?
The interventions under investigation include: Placebo (DRUG), DSP-1053 (DRUG).
Who is sponsoring clinical trial NCT01774747?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01774747's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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