Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam

Emalex Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 180 mg controlled release form; Drug: Ecopipam immediate release form; Drug: 90 mg controlled release form

Study type: Interventional

Funder types: Industry

Identifiers

NCT01408394

PSY401

Details and patient eligibility

About

Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible diseases. To date, all clinical studies have been done using the ecopipam immediate release (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been produced that may be able to improve its effectiveness and reduce its side effects. The main purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when given as single oral dose in healthy volunteers.

Full description

Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible diseases. To date, all clinical studies have been done using the ecopipam immediate release (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been produced that may be able to improve its effectiveness and reduce its side effects. The main purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when given as single oral dose in healthy volunteers. Another purpose of the study is to measure how much CR and IR ecopipam gets into the blood stream, and how long the body takes to get rid of them. Information about any side effects that may occur will be collected.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups

100 mg immediate release form

Active Comparator group

Description:

This is the formulation currently in use

Treatment:

Drug: Ecopipam immediate release form

90 mg controlled release

Experimental group

Description:

This is the low dose of the controlled release form

Treatment:

Drug: 90 mg controlled release form

180 mg controlled release form

Experimental group

Description:

This is the medium controlled release dose

Treatment:

Drug: 180 mg controlled release form