Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT01408394
Eligibility Criteria:
Inclusion Criteria:
1. Signed and dated, IRB-approved informed consent form before any protocol-specific screening procedures
2. Non-smoking male subjects between the ages of 18 and 45 years (inclusive)
3. In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
4. Willing and able to complete all study assessments and procedures
5. Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 65 and 100 kg (inclusive)
6. QTcB interval (Bazett's correction factor) of the baseline ECG must be ≤ 450 ms at screening
Exclusion Criteria:
1. Subjects with a history of suicide attempt or with past or current active suicidal ideation
2. Subjects with a history of seizures or with head trauma leading to loss of consciousness
3. Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
4. History of any primary malignancy, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
5. Supine blood pressure \>140/90 mm/Hg or resting heart rate ≥100 bpm at the screening visit
6. History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) or eating disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) within 1 year of screening
7. History of smoking or the use of nicotine containing products within 3 months of screening by self reporting
8. A positive alcohol Breathalyzer or urine drug screen for drugs of abuse at the screening visit or at the beginning of the inpatient period
9. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period
10. Treatment with any other prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 7 days or 5 half-lives of the screening visit, whichever is longer. Acetaminophen will be permitted for intermittent treatment at doses of less than 2 grams/day
11. Subjects with a history of previous administration of ecopipam or of an allergic reaction or hypersensitivity to any drug or to any component of the CR formulation
12. Blood collection or blood loss of greater than 500 mL within 56 days prior to screening
13. Positive for human immunodeficiency virus (HIV) at screening
14. Positive for Hepatitis B surface antigen (HbsAg) or positive Hepatitis C virus (HCV) antibody at screening
15. Any other condition and/or situation that causes the investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01408394
Study Brief:
Protocol Section:
NCT01408394