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

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia or Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT02567370

Run by

Amgen

People needed

70

Starts

2015-08-01

Expected to finish

2015-10-01

Last updated by the study team

2015-10-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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