HealthyPhase 1NCT01408394
Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam
A Phase 1 study testing Ecopipam immediate release form in people with Healthy, run by Emalex Biosciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ecopipam immediate release form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ecopipam immediate release form, 90 mg controlled release form, 180 mg controlled release form
- Keywords
- safety, pharmacokinetics, controlled release, formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecopipam immediate release formDrug
Also called SCH 39166, PSYRX101
Tablet containing 100 mg of the immediate release form of ecopipam
90 mg controlled release formDrug
Also called SCH 39166, PSYRX101
This is the 90 mg controlled release form
180 mg controlled release formDrug
Also called SCH 39166, PSYRX101
This is the 180 mg controlled release capsule
| Study group | Role | What they receive |
|---|---|---|
| 100 mg immediate release form | Active comparator | This is the formulation currently in use Receives: Drug: Ecopipam immediate release form |
| 90 mg controlled release | Experimental | This is the low dose of the controlled release form Receives: Drug: 90 mg controlled release form |
| 180 mg controlled release form | Experimental | This is the medium controlled release dose Receives: Drug: 180 mg controlled release form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Physical examinations, adverse events, vital signs, clinical laboratory values, ECG and Columbia Suicide Severity Ratings scale
Measured: 0-48 hours
Secondary outcomes (1)
Pharmacokinetics
Pharmacokinetic properties of CR and IR ecopipam following oral administration
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Psyadon Pharma
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MB,ChB,FACP, Principal investigator, SNBL Clinical Pharmacology Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408394
- Sponsor's protocol ID
- PSY401
- Status last verified
- May 2013
- First submitted
- 1 Aug 2011
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01408394
- Acronym / sponsor ID
- PSY401
- Conditions
- Healthy
- Keywords
- safety, pharmacokinetics, controlled release, formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Psyadon Pharma
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100 mg immediate release form | Active comparator | Drug: Ecopipam immediate release formThis is the formulation currently in use |
| 90 mg controlled release | Experimental | Drug: 90 mg controlled release formThis is the low dose of the controlled release form |
| 180 mg controlled release form | Experimental | Drug: 180 mg controlled release formThis is the medium controlled release dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecopipam immediate release formAlso: SCH 39166, PSYRX101Tablet containing 100 mg of the immediate release form of ecopipam | Drug | 100 mg immediate release form |
| 90 mg controlled release formAlso: SCH 39166, PSYRX101This is the 90 mg controlled release form | Drug | 90 mg controlled release |
| 180 mg controlled release formAlso: SCH 39166, PSYRX101This is the 180 mg controlled release capsule | Drug | 180 mg controlled release form |
Primary outcome
Safety
Time frame: 0-48 hours
Physical examinations, adverse events, vital signs, clinical laboratory values, ECG and Columbia Suicide Severity Ratings scale
1 secondary outcome
Pharmacokinetics
Time frame: 0-48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Al-Ibrahim, MB,ChB,FACP principal investigator
SNBL Clinical Pharmacology Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ecopipam immediate release form in people with Healthy, run by Emalex Biosciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 0-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.