NCT02504476

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 in healthy participants and subjects with schizophrenia and whether it causes any side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 8, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

July 8, 2015

Last Update Submit

March 4, 2016

Conditions

Schizophrenia or Schizoaffective Disorder

Keywords

Schizophrenia or Schizoaffective Disorder

Outcome Measures

Primary Outcomes (11)

  • Reported treatment-emergent adverse events

    Number and percent of subjects experiencing adverse events

    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

    39 days

  • Changes in heart rate

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

    39 days

  • Changes in respiratory rate

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

    39 days

  • Changes in temperature

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

    39 days

  • Changes in ECGs

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

    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

    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

    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

    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

    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

    39 days

Secondary Outcomes (4)

  • Compare PK parameter (Cmax) between Day 1 and Day 18

    18 days

  • Compare PK parameter (AUC) between Day 1 and Day 18

    18 days

  • Compare PK parameter (tmax) Compare PK parameter (tmax) between Day 1 and Day 18

    18 days

  • Plasma PK parameters of midazolam and 1-OH midazolam

    36 days

Other Outcomes (5)

  • AMG 581 metabolites in plasma

    39 days

  • Cmax and AUC of AMG 581 prior to versus following midazolam administration

    36 days

  • Subjective experience following administration of AMG 581

    39 days

  • +2 more other outcomes

Study Arms (9)

AMG 581 - Dose 1

ACTIVE COMPARATOR
Drug: AMG 581

AMG 581 - Dose 2

ACTIVE COMPARATOR
Drug: AMG 581

AMG 581 - Dose 3

ACTIVE COMPARATOR
Drug: AMG 581

AMG 581 - Dose 4

ACTIVE COMPARATOR
Drug: AMG 581

Placebo - Dose 1

PLACEBO COMPARATOR
Drug: AMG 581Drug: Placebo

Placebo - Dose 2

PLACEBO COMPARATOR
Drug: Placebo

Placebo - Dose 3

PLACEBO COMPARATOR
Drug: Placebo

Placebo - Dose 4

PLACEBO COMPARATOR
Drug: Placebo

AMG 581/Midazolam - Drug Interaction

OTHER
Drug: AMG 581Drug: Midazolam

Interventions

AMG 581DRUG

Active drug

AMG 581 - Dose 1AMG 581 - Dose 2AMG 581 - Dose 3AMG 581 - Dose 4AMG 581/Midazolam - Drug InteractionPlacebo - Dose 1
PlaceboDRUG

Placebo

Placebo - Dose 1Placebo - Dose 2Placebo - Dose 3Placebo - Dose 4
MidazolamDRUG

Interaction

AMG 581/Midazolam - Drug Interaction

Eligibility Criteria

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

You may qualify if:

  • \- Provided informed consent prior to initiation of any study-specific activities/procedures; -male or female subjects should be between the ages of 18 and 45 years (18-55 years for subjects with schizophrenia);-non-nicotine or non-tobacco (healthy subjects only); - no history of relevant medical disorders; - BMI ≥ 18.0; - females of non-reproductive potential; - males practicing effective birth control; - avoid tanning/direct sunlight; - schizophrenia or schizoaffective disorder; PANSS score ≤ 4 points on following 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; essential tremor or gait disturbance; - history of hereditary shorten QT syndrome; - malignancy or tumor (other than skin cancers); - history of GI disease that could interfere with absorption; - QTc ≥ 450 msec or ≤ 380 msec; - HbA1c ≥ 7%;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Glendale, California, 91206, United States

Location

Parexel

Glendale, California, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

July 8, 2015

First Posted

July 22, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

US(2)