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NCT02504476 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective
A Phase 1 study of Schizophrenia or Schizoaffective Disorder, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 2
- Study locations
NCT02504476: Completed Phase 1 study of Schizophrenia or Schizoaffective Disorder, sponsored by Amgen.
NCT02504476 is a Phase 1 study of Schizophrenia or Schizoaffective Disorder that has completed, run by Amgen. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02504476, a Phase 1 study of Schizophrenia or Schizoaffective Disorder, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body in healthy participants and subjects with schizophrenia and whether it causes any side effects.
Primary Outcome
Number and percent of subjects experiencing adverse events
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Midazolam
- DRUG AMG 581
Study Locations (2)
California
- Research Site - Glendale
- Parexel - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT02504476 record still lists
NCT02504476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Schizophrenia or Schizoaffective Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02504476 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02504476 about?
NCT02504476 is a clinical study titled "Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective". The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body in healthy participants and subjects with schizophrenia and whether it causes any side effects.
What is the current status of trial NCT02504476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2015-08. Estimated completion is 2016-02.
What conditions does trial NCT02504476 study?
This clinical trial studies the following conditions: Schizophrenia or Schizoaffective Disorder.
What interventions are being tested in trial NCT02504476?
The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), AMG 581 (DRUG).
Who is sponsoring clinical trial NCT02504476?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02504476 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02504476's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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