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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen

Criteria

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