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Study Complete
Sponsor ID
20130259

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

Sponsor ID
20130259
Clinicaltrials.gov ID
NCT02504476
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 581
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
52
Additional Study Details

Protocol Summary

Primary Outcome Measures

Reported treatment-emergent adverse events

Timeframe: 39 days

Changes in systolic/diastolic blood pressure

Timeframe: 39 days

Changes in heart rate

Timeframe: 39 days

Changes in respiratory rate

Timeframe: 39 days

Changes in temperature

Timeframe: 39 days

Changes in ECGs

Timeframe: 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

Timeframe: 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

Timeframe: 39 days

Scores at each study visit for Simpson Angus Scale (SAS)

Timeframe: 39 days

Scores at each study visit for Barnes Akathisia Rating Scale (BARS)

Timeframe: 39 days

Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: 39 days

Secondary Outcome Measures

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

Timeframe: 18 days

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

Timeframe: 18 days

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

Timeframe: 18 days

Plasma PK parameters of midazolam and 1-OH midazolam

Timeframe: 36 days

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Parexel
Glendale, CA, United States
Status
Not yet recruiting
Location
Research Site
Glendale, CA, United States, 91206
Status
Recruiting
Study Info
Age
18 - 45 Years
Condition
  • Schizophrenia
    • Sex
    All
    Trial Dates
    Aug 2015 - Feb 2016
    Inclusion and Exclusion Criteria
    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%;