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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Single Center, Randomized (2-Sequence), Single Blind, 3-Period Study Comparing the Safety, Tolerability, and Pharmacokinetics of Ecopipam Controlled Release Capsules With Ecopipam HCl Immediate Release Tablets in Male Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ecopipam immediate release form
* Drug: 90 mg controlled release form
* Drug: 180 mg controlled release form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated, IRB-approved informed consent form before any protocol-specific screening procedures Non-smoking male subjects between the ages of 18 and 45 years (inclusive) In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation Willing and able to complete all study assessments and procedures Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 65 and 100 kg (inclusive) QTcB interval (Bazett's correction factor) of the baseline ECG must be ≤ 450 ms at screening Exclusion Criteria: Subjects with a history of suicide attempt or with past or current active suicidal ideation Subjects with a history of seizures or with head trauma leading to loss of consciousness Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study 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 Supine blood pressure >140/90 mm/Hg or resting heart rate ≥100 bpm at the screening visit 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 History of smoking or the use of nicotine containing products within 3 months of screening by self reporting A positive alcohol Breathalyzer or urine drug screen for drugs of abuse at the screening visit or at the beginning of the inpatient period Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period 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 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 Blood collection or blood loss of greater than 500 mL within 56 days prior to screening Positive for human immunodeficiency virus (HIV) at screening Positive for Hepatitis B surface antigen (HbsAg) or positive Hepatitis C virus (HCV) antibody at screening 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 100 mg immediate release form<br>This is the formulation currently in use | Drug: Ecopipam immediate release form<br>* Tablet containing 100 mg of the immediate release form of ecopipam<br>* Other names: PSYRX101;|
| Experimental: 90 mg controlled release<br>This is the low dose of the controlled release form | Drug: 90 mg controlled release form<br>* This is the 90 mg controlled release form<br>* Other names: PSYRX101;|
| Experimental: 180 mg controlled release form<br>This is the medium controlled release dose | Drug: 180 mg controlled release form<br>* This is the 180 mg controlled release capsule<br>* Other names: PSYRX101;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The safety of ecopipam will be assessed from physical examination, including AE reporting, vital signs (blood pressure, heart rate), clinical laboratory values (hematology, biochemistry, and urinalysis), and ECGs. | 0-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | The pharmacokinetics of ecopipam following oral administration will be assessed from plasma concentrations of medication. | 0-48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, pharmacokinetics, controlled release, formulation