Study Complete
Sponsor ID
20130100
Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581FIH
Study Details
The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body, safety and tolerability of AMG 581 in healthy participants and subjects with schizophrenia.
Protocol Summary
Primary Outcome Measures
Reported treatment-emergent adverse events
Timeframe: 15 days
Changes in systolic/diastolic blood pressure
Timeframe: 15 days
Changes in heart rate
Timeframe: 15 days
Changes in respiratory rate
Timeframe: 15 days
Changes in temperature
Timeframe: 15 days
Changes in ECGs
Timeframe: 15 days
Scores at each study visit for Simpson Angus Scale (SAS)
Timeframe: 15 days
Scores at each study visit and summary by cohort for Barnes Akathisia Rating Scale (BARS)
Timeframe: 15 days
Subject incidence of treatment-emergent suicidal ideation and behavior as measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: 15 days
Secondary Outcome Measures
Peak plasma concentration (Cmax)
Timeframe: 15 days
Area under the plasma concentration versus time curve (AUC)
Timeframe: 15 days
Median of tmax
Timeframe: 15 days
Locations
Location
Research Site
Glendale, CA, United States, 91206
Status
Recruiting