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NCT01531972 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-Label, Single-photon Emission Computed Tomography (SPECT) Study to Evaluate Serotonin and Dopamine Transporter Occupancy After Multiple Dose Administration of SEP-228432 to Achieve Steady State in Healthy Subjects
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01531972: Completed Phase 1 study, sponsored by Sumitomo Pharma America.
NCT01531972 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531972, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an open-label study investigating the relationship between SEP-228432 and SEP-228431 (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT occupancy, both measured by SPECT imaging.
Primary Outcome
SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects.
Interventions
- DRUG SEP-228432
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01531972 record still lists
NCT01531972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which SEP-228432 is the first listed.
NCT01531972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01531972 about?
NCT01531972 is a clinical study titled "A Phase 1, Open-Label, Single-photon Emission Computed Tomography (SPECT) Study to Evaluate Serotonin and Dopamine Transporter Occupancy After Multiple Dose Administration of SEP-228432 to Achieve Steady State in Healthy Subjects". This is an open-label study investigating the relationship between SEP-228432 and SEP-228431 (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT occupancy, both measured by SPECT imaging.
What is the current status of trial NCT01531972?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01531972?
The interventions under investigation include: SEP-228432 (DRUG).
Who is sponsoring clinical trial NCT01531972?
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 NCT01531972's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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