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NCT03356639 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of ASP6981 in Subjects With Schizophrenia
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03356639: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT03356639 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03356639, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The primary purpose is to evaluate the safety and tolerability of ASP6981 in participants with schizophrenia. Also primary purpose is to evaluate the pharmacodynamics of ASP6981 in participants with schizophrenia as measured by cognitive function and neurophysiological biomarkers. The secondary purpose of this study is to evaluate the pharmacokinetics of ASP6981 in participants with schizophrenia.
Primary Outcome
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Interventions
- DRUG Placebo
- DRUG ASP6981
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-01-22 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 1 |
What the finished NCT03356639 record still lists
NCT03356639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03356639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03356639 about?
NCT03356639 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of ASP6981 in Subjects With Schizophrenia". The primary purpose is to evaluate the safety and tolerability of ASP6981 in participants with schizophrenia. Also primary purpose is to evaluate the pharmacodynamics of ASP6981 in participants with schizophrenia as measured by cognitive function and neurophysiological biomarkers. The secondary pu...
What is the current status of trial NCT03356639?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-01-22. Estimated completion is 2018-05-30.
What interventions are being tested in trial NCT03356639?
The interventions under investigation include: Placebo (DRUG), ASP6981 (DRUG).
Who is sponsoring clinical trial NCT03356639?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03356639's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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