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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Psyadon Pharma
ClinicalTrials.gov Identifier:
NCT01408394
First received: August 1, 2011
Last updated: August 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Ecopipam immediate release form
Drug: 90 mg controlled release form
Drug: 180 mg controlled release form
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Psyadon Pharma:

Primary Outcome Measures:
  • Safety [ Time Frame: 0-48 hours ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
    The pharmacokinetics of ecopipam following oral administration will be assessed from plasma concentrations of medication.


Enrollment: 16
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 100 mg immediate release form
This is the formulation currently in use
Drug: Ecopipam immediate release form
Tablet containing 100 mg of the immediate release form of ecopipam
Other Names:
  • SCH 39166
  • PSYRX101
Experimental: 90 mg controlled release
This is the low dose of the controlled release form
Drug: 90 mg controlled release form
This is the 90 mg controlled release form
Other Names:
  • SCH 39166
  • PSYRX101
Experimental: 180 mg controlled release form
This is the medium controlled release dose
Drug: 180 mg controlled release form
This is the 180 mg controlled release capsule
Other Names:
  • SCH 39166
  • PSYRX101

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408394

Locations
United States, Maryland
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Psyadon Pharma
Investigators
Principal Investigator: Mohamed Al-Ibrahim, MB,ChB,FACP SNBL Clinical Pharmacology Center Inc.
  More Information

No publications provided

Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT01408394     History of Changes
Other Study ID Numbers: PSY401
Study First Received: August 1, 2011
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Psyadon Pharma:
safety
pharmacokinetics
controlled release
formulation

Additional relevant MeSH terms:
Ecopipam
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014