Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581

Amgen70 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia or Schizoaffective Disorder

Interventions

AMG 581DRUG

Active drug

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Research Site

Glendale, California, United States

Outcomes

Primary Outcomes

Reported treatment-emergent adverse events

Number and percent of subjects experiencing adverse events

Time frame: 15 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: 15 days

Changes in heart rate

Summaries over time and/or changes from baseline over time in heart rate

Time frame: 15 days

Changes in respiratory rate

Summaries over time and/or changes from baseline over time in respiratory rate

Time frame: 15 days

Changes in temperature

Summaries over time and/or changes from baseline over time in temperature

Time frame: 15 days

Changes in ECGs

Summaries over time and/or changes from baseline over time in ECGs

Time frame: 15 days

Scores at each study visit for Simpson Angus Scale (SAS)

Summaries over time and/or changes from baseline over time in Simpson Angus Scale (SAS) score

Time frame: 15 days

Scores at each study visit and summary by cohort for Barnes Akathisia Rating Scale (BARS)

Summaries over time and/or changes from baseline over time in Barnes Akathisia Rating Scale (BARS) score

Time frame: 15 days

Subject incidence of treatment-emergent suicidal ideation and behavior as measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

Data from ClinicalTrials.gov

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Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes