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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

First-in-Human Study to Evaluate AMG 579 in Healthy Subjects and Patients With Stable Schizophrenia

NCT01568203

Schizophrenia

TERMINATED PHASE1

20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

NCT01568216

Schizophrenia

TERMINATED PHASE2

20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)

NCT01568229

Schizophrenia

TERMINATED PHASE2

Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

NCT00570063

Schizophrenia

TERMINATED PHASE2

Ketogenic Diet in People With Schizophrenia

NCT05968638

Schizophrenia Schizo Affective Disorder

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia or Schizoaffective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

AMG 581

Group Type ACTIVE_COMPARATOR

AMG 581

Intervention Type DRUG

Active drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AMG 581

Active drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes