Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia or Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 581 - Dose 1

Group Type ACTIVE_COMPARATOR

AMG 581

Intervention Type DRUG

Active drug

AMG 581 - Dose 2

Group Type ACTIVE_COMPARATOR

AMG 581

Intervention Type DRUG

Active drug

AMG 581 - Dose 3

Group Type ACTIVE_COMPARATOR

AMG 581

Intervention Type DRUG

Active drug

AMG 581 - Dose 4

Group Type ACTIVE_COMPARATOR

AMG 581

Intervention Type DRUG

Active drug

Placebo - Dose 1

Group Type PLACEBO_COMPARATOR

AMG 581

Intervention Type DRUG

Active drug

Placebo

Intervention Type DRUG

Placebo

Placebo - Dose 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Placebo - Dose 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Placebo - Dose 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

AMG 581/Midazolam - Drug Interaction

Group Type OTHER

AMG 581

Intervention Type DRUG

Active drug

Midazolam

Intervention Type DRUG

Interaction

Interventions

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AMG 581

Active drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Midazolam

Interaction

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- 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

Exclusion Criteria

* 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%;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes