Food-effectPhase 1NCT06669091
Food-effect Study of Ecopipam Pharmacokinetics
A Phase 1 study testing Ecopipam tablet in people with Food-effect, run by Emalex Biosciences Inc. at 1 site in United States.
Trial summary
Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food-effect
- What is being tested?
- Ecopipam tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 27 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects or female subjects of non-childbearing potential
- ≥18 and ≤55 years of age
- BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, and standard panel of blood and laboratory tests at Screening.
- Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug.
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
Who cannot join
- History of significant medical illness
- Clinically significant abnormalities on screening tests/exams
- History of or significant risk of committing suicide
- Donation of plasma within 1 month prior to dosing
- Donation or significant loss of blood within 8 weeks prior to the first dosing
- Major surgery within 3 months or minor surgery within 1 month prior to admission
Show all 16Show fewer
- Use of prohibited prescription, over-the-counter medications or natural health products
- Use of tobacco or nicotine products within 1 month prior to Screening
- Significant alcohol consumption or history of abuse
- History of drug abuse within the previous 2 years, or a positive drug screen
- History of cannabinoid use within the previous 3 months
- Positive urine drug screen, urine cotinine test, or alcohol breath test
- History of allergy to study medications
- Recent participation in a clinical research study
- Prior exposure to ecopipam
- Not suitable for study in the opinion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, 2-way Crossover, Food-effect Study of Ecopipam Pharmacokinetics After Administration of the to Be Marketed Tablet in Healthy Subjects
Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.
- Conditions
- Food-effect
- Being tested
- Ecopipam tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecopipam tabletDrug
A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)
| Study group | Role | What they receive |
|---|---|---|
| Dosed in fasted state | Other | Ecopipam will be taken in the morning in a fasted state Receives: Drug: Ecopipam tablet |
| Dosed in fed state | Other | Ecopipam will be taken in the morning after a standard high-fat breakfast Receives: Drug: Ecopipam tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of ecopipam after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of ecopipam after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUC of ecopipam after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of ecopipam after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of ecopipam after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Cmax of ecopipam after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of ecopipam after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUC of ecopipam after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of ecopipam after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Secondary outcomes (44)
Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 13
Safety and tolerability as demonstrated by concomitant medications
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Safety and tolerability as demonstrated by physical exams
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Safety and tolerability as demonstrated by AEs
Subjects will be continually monitored for adverse events
Measured: Up to Day 20
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Respiratory rate (breaths/minute)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Oral temperature (degrees Celsius)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Value of hematocrit (percent)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Value of hemoglobin (g/dL)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Red blood cell (RBC) count (M/mm3)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Values of urea, phosphorus, calcium, glucose, total cholesterol, HDL, LDL, triglycerides, uric acid, and total, direct and indirect bilirubin (mg/dL)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Values of albumin and total protein (g/dL)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Values of amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), creatine phosphokinase (CPK), and creatinine (U/L)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Value of urine pH
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Value of urine glucose
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Value of urine protein
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Value of urine blood
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Value of urine leukocyte esterase by dipstick
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start5 Nov 2024
- Primary completion22 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food-effectStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Munschauer, MSc, MD, FAAN, Study chair, Emalex Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669091
- Sponsor's protocol ID
- EBS-101-HV-107
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, 2-way Crossover, Food-effect Study of Ecopipam Pharmacokinetics After Administration of the to Be Marketed Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06669091
- Acronym / sponsor ID
- EBS-101-HV-107
- Conditions
- Food-effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 1 Nov 2024 (actual)
- 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.
Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosed in fasted state | Other | Drug: Ecopipam tabletEcopipam will be taken in the morning in a fasted state |
| Dosed in fed state | Other | Drug: Ecopipam tabletEcopipam will be taken in the morning after a standard high-fat breakfast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male subjects or female subjects of non-childbearing potential
- ≥18 and ≤55 years of age
- BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, and standard panel of blood and laboratory tests at Screening.
- Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug.
Key exclusion criteria (16 listed)
- History of significant medical illness
- Clinically significant abnormalities on screening tests/exams
- History of or significant risk of committing suicide
- Donation of plasma within 1 month prior to dosing
- Donation or significant loss of blood within 8 weeks prior to the first dosing
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 tabletA single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg) | Drug | Dosed in fasted state, Dosed in fed state |
Primary outcome
Cmax of ecopipam after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Tmax of ecopipam after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC of ecopipam after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of ecopipam after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Tmax of ecopipam after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC of ecopipam after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of ecopipam after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
44 secondary outcomes
Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
Time frame: Up to Day 13
Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
Time frame: Up to Day 13
Safety and tolerability as demonstrated by concomitant medications
Time frame: Up to Day 20
Safety and tolerability as demonstrated by physical exams
Time frame: Up to Day 20
Safety and tolerability as demonstrated by AEs
Time frame: Up to Day 20
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Time frame: Up to Day 20
Respiratory rate (breaths/minute)
Time frame: Up to Day 20
Oral temperature (degrees Celsius)
Time frame: Up to Day 20
Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)
Time frame: Up to Day 20
Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
Time frame: Up to Day 20
Value of hematocrit (percent)
Time frame: Up to Day 20
Value of hemoglobin (g/dL)
Time frame: Up to Day 20
Red blood cell (RBC) count (M/mm3)
Time frame: Up to Day 20
Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L)
Time frame: Up to Day 20
Values of urea, phosphorus, calcium, glucose, total cholesterol, HDL, LDL, triglycerides, uric acid, and total, direct and indirect bilirubin (mg/dL)
Time frame: Up to Day 20
Values of albumin and total protein (g/dL)
Time frame: Up to Day 20
Values of amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), creatine phosphokinase (CPK), and creatinine (U/L)
Time frame: Up to Day 20
Value of urine pH
Time frame: Up to Day 20
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 27 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Frederick Munschauer, MSc, MD, FAAN study chair
Emalex Biosciences
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 tablet in people with Food-effect, 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 16 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 27 Jan 2025. 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?
Cmax of ecopipam after administration of an ecopipam tablet in the fed state (time frame: Up to Day 13). The study lists 10 primary outcomes in all. 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 27 Jan 2025.