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NCT01994473 · ClinicalTrials.gov registry record · Phase 1
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01994473 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 48 participants.
The verdict
NCT01994473, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.
Interventions
- DRUG Placebo
- DRUG SEP-363856
- DRUG SEP-363856 Open Label
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01994473
The ClinicalTrials.gov registry entry for NCT01994473 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01994473 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01994473 about?
NCT01994473 is a clinical study titled "Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia". This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.
What is the current status of trial NCT01994473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01994473?
The interventions under investigation include: Placebo (DRUG), SEP-363856 (DRUG), SEP-363856 Open Label (DRUG).
Who is sponsoring clinical trial NCT01994473?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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