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

NCT01408394 | Completed Phase 1

• 1 other identifier: PSY401
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

safety; pharmacokinetics; controlled release; formulation

Outcome Measures

Primary Outcomes (1)

• Safety

  Physical examinations, adverse events, vital signs, clinical laboratory values, ECG and Columbia Suicide Severity Ratings scale

  0-48 hours

Secondary Outcomes (1)

• Pharmacokinetics

  0-48 hours

Study Arms (3)

100 mg immediate release form

ACTIVE COMPARATOR

This is the formulation currently in use

Drug: Ecopipam immediate release form

90 mg controlled release

EXPERIMENTAL

This is the low dose of the controlled release form

Drug: 90 mg controlled release form

180 mg controlled release form

EXPERIMENTAL

This is the medium controlled release dose

Drug: 180 mg controlled release form

Interventions

Ecopipam immediate release form DRUG

Tablet containing 100 mg of the immediate release form of ecopipam

Also known as: SCH 39166, PSYRX101

100 mg immediate release form

90 mg controlled release form DRUG

This is the 90 mg controlled release form

Also known as: SCH 39166, PSYRX101

90 mg controlled release

180 mg controlled release form DRUG

This is the 180 mg controlled release capsule

Also known as: SCH 39166, PSYRX101

180 mg controlled release form

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead
• Psyadon Pharma: collaborator

Study Sites (1)

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

ecopipam

Study Officials

• Mohamed Al-Ibrahim, MB,ChB,FACP

  SNBL Clinical Pharmacology Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 3, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 19, 2024

Record last verified: 2013-05

Locations

US (1)