Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581
- Conditions
- Schizophrenia or Schizoaffective Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT02567370
- Lead Sponsor
- Amgen
- Brief 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, safety and tolerability of AMG 581 in healthy participants and subjects with schizophrenia.
- Detailed Description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of single-ascending oral doses of AMG 581 in healthy subjects and subjects diagnosed with schizophrenia or schizoaffective disorder receiving antipsychotic treatment.
This will be a placebo-controlled, single-ascending oral-dose study of AMG 581 with a food-effect cohort. Approximately 70 subjects will be enrolled. This study will enroll healthy subjects into 8 cohorts (Cohorts 1,2,3,4,5,6,8 and 9), and subjects with schizophrenia or schizoaffective disorder receiving antipsychotic medication into a single cohort (Cohort 7).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Provide informed consent prior to initiation of any study-related procedure
- Male and female subjects ≥ 18 to ≤ 45 years of age at the time of screening
- Non-nicotine or non-tobacco for healthy subjects
- No history of relevant medical disorders
- BMI ≥ 18.0 and ≤ 30.0
- Non-reproductive females
- Males practicing effect birth control
- Avoid tanning/direct sunlight
- Willing to consume high-fat meal
- Schizophrenia or schizoaffective disorder
- PANSS score ≤ 4 points on a few items (i.e. conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, depression, anxiety, disorientation, uncooperativeness, disturbance of volition, and poor impulse control) / total score ≤ 80 points
- Females lactating/breastfeeding
- Pregnant partners of male subjects
- Tremor or gait disturbance
- History of hereditary shorten QT syndrome
- Malignancy or tumor (other than skin cancers)
- History of GI disease
- QTc ≥ 450 msec or ≤ 380 msec
- Creatinine clearance < 80 mL/min at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - AMG 581 AMG 581 -
- Primary Outcome Measures
Name Time Method Changes in heart rate 15 days Summaries over time and/or changes from baseline over time in heart rate
Changes in respiratory rate 15 days Summaries over time and/or changes from baseline over time in respiratory rate
Scores at each study visit for Simpson Angus Scale (SAS) 15 days Summaries over time and/or changes from baseline over time in Simpson Angus Scale (SAS) score
Reported treatment-emergent adverse events 15 days Number and percent of subjects experiencing adverse events
Scores at each study visit and summary by cohort for Barnes Akathisia Rating Scale (BARS) 15 days Summaries over time and/or changes from baseline over time in Barnes Akathisia Rating Scale (BARS) score
Subject incidence of treatment-emergent suicidal ideation and behavior as measured by Columbia-Suicide Severity Rating Scale (C-SSRS) 15 days Subject incidence of treatment-emergent suicidal ideation and behavior as measured by Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
Changes in temperature 15 days Summaries over time and/or changes from baseline over time in temperature
Changes in ECGs 15 days Summaries over time and/or changes from baseline over time in ECGs
Changes in systolic/diastolic blood pressure 15 days Summaries over time and/or changes from baseline over time in systolic and/or diastolic blood pressure
- Secondary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) 15 days Peak plasma concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 15 days Area under the plasma concentration versus time curve (AUC)
Median of tmax 15 days Median of tmax
Trial Locations
- Locations (1)
Research Site
🇺🇸Glendale, California, United States