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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 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 30 participants.

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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.

Interventions

  • DRUG SEP-228432

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-02
Est. Completion 2012-05
Phase Phase 1

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT01531972

The ClinicalTrials.gov registry entry for NCT01531972 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which SEP-228432 is the first listed.

NCT01531972 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.