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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of ascending multiple oral doses of AMG 581 in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication. The study will also assess the effects of AMG 581 on midazolam PK in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Research Site
Glendale, California, United States
Parexel
Glendale, California, United States
Reported treatment-emergent adverse events
Number and percent of subjects experiencing adverse events
Time frame: 39 days
Changes in systolic/diastolic blood pressure
Summaries over time and/or changes from baseline over time in systolic and/or diastolic blood pressure
Time frame: 39 days
Changes in heart rate
Summaries over time and/or changes from baseline over time in heart rate
Time frame: 39 days
Changes in respiratory rate
Summaries over time and/or changes from baseline over time in respiratory rate
Time frame: 39 days
Changes in temperature
Summaries over time and/or changes from baseline over time in temperature
Time frame: 39 days
Changes in ECGs
Summaries over time and/or changes from baseline over time in ECGs
Time frame: 39 days
Maximum change from baseline in QTc in ECGs and number and percentage of subjects with maximum changes exceeding prespecified limits in each group
Subjects' maximum change from baseline in QTc and the number and percentage of subjects in each group
Time frame: 39 days
Maximum post-baseline QTc values and number and percentage of subjects with maximum post-baseline QTc values exceeding prespecified limits in each group
Subjects' maximum post-baseline values and the number and percentage of subjects in each group
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 39 days
Scores at each study visit for Simpson Angus Scale (SAS)
Summaries over time and/or changes from baseline over time in changes in Simpson Angus Scale (SAS) score
Time frame: 39 days
Scores at each study visit for Barnes Akathisia Rating Scale (BARS)
Summaries over time and/or changes from baseline over time in in Barnes Akathisia Rating Scale (BARS) score
Time frame: 39 days
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
Time frame: 39 days
Compare PK parameter (Cmax) between Day 1 and Day 18
Compare PK parameter (Cmax) between Day 1 and Day 18
Time frame: 18 days
Compare PK parameter (AUC) between Day 1 and Day 18
Compare PK parameter (AUC) between Day 1 and Day 18
Time frame: 18 days
Compare PK parameter (tmax) Compare PK parameter (tmax) between Day 1 and Day 18
Compare PK parameter (tmax) Compare PK parameter (tmax) between Day 1 and Day 18
Time frame: 18 days
Plasma PK parameters of midazolam and 1-OH midazolam
Cmax and AUC prior to versus following AMG 581 administration
Time frame: 36 days