NCT02567370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

September 16, 2015

Last Update Submit

October 22, 2015

Conditions

Schizophrenia or Schizoaffective Disorder

Keywords

Schizophrenia or Schizoaffective Disorder

Outcome Measures

Primary Outcomes (9)

  • Reported treatment-emergent adverse events

    Number and percent of subjects experiencing adverse events

    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

    15 days

  • Changes in heart rate

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

    15 days

  • Changes in respiratory rate

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

    15 days

  • Changes in temperature

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

    15 days

  • Changes in ECGs

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

    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

    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

    15 days

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

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

    15 days

Secondary Outcomes (3)

  • Peak plasma concentration (Cmax)

    15 days

  • Area under the plasma concentration versus time curve (AUC)

    15 days

  • Median of tmax

    15 days

Other Outcomes (5)

  • AMG 581 metabolites in plasma

    15 days

  • Subjective experience follow administration of AMG 581 as measured by the Bond and Lader visual analogue scale (VAS)

    15 days

  • Subjective experience follow administration of AMG 581 as measured by the Positive and Negative Syndrome Scale (PANSS)

    15 days

  • +2 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

AMG 581

ACTIVE COMPARATOR
Drug: AMG 581

Interventions

AMG 581DRUG

Active drug

AMG 581
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

October 5, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

US(1)