Drug InteractionPhase 1NCT06194864
Drug Interaction Study
A Phase 1 study testing Itraconazole, rifampicin and Ecopipam in people with Drug Interaction, run by Emalex Biosciences Inc. at 1 site in Canada.
Trial summary
This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Itraconazole, rifampicin and Ecopipam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2024to 22 May 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 femail 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.
- Willing to take off dentures or mouth piercing at the time of dosing.
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 7 days 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 17Show fewer
- Use of prohibited prescription, over-the-counter medications or natural health products
- Female subjects who are currently pregnant or lactating
- Positive pregnancy test
- Positive urine drug screen, urine cotinine test, or alcohol breath test
- Use of tobacco or nicotine products within 1 month prior to Screening
- Significant alcohol consumption
- History of drug abuse within the previous year, or a positive drug screen
- History of allergy to study medications
- Part 1 only: Presence of orthodontic braces or orthodontic retention wires
- Recent participation in a clinical research study
- 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, Sequential Drug Interaction Study to Evaluate the Effect of CYP3A4 and P-glycoprotein Inhibition by Itraconazole or Induction by Rifampicin on the Pharmacokinetics of Ecopipam and Its Metabolites in Healthy Subjects
This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.
- Conditions
- Drug Interaction
- Being tested
- Itraconazole, rifampicin, Ecopipam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
itraconazole 200 mg QD Days 6 to 16
rifampicinDrug
rifampicin 600 mg QD Days 6 to 20
EcopipamDrug
89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16. Receives: Drug: Itraconazole; Drug: Ecopipam |
| Part 2 | Experimental | ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20. Receives: Drug: rifampicin; Drug: Ecopipam |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf of ecopipam when administered with itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-inf of ecopipam when administered without itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-inf of ecopipam when administered with rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-inf of ecopipam when administered without rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-t of ecopipam when administered with itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-t of ecopipam when administered without itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-t of ecopipam when administered with rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-t of ecopipam when administered without rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Cmax of ecopipam when administered with itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Cmax of ecopipam when administered without itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Cmax of ecopipam when administered with rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Cmax of ecopipam when administered without rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
T½ el of ecopipam when administered with itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
T½ el of ecopipam when administered without itraconazole
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
T½ el of ecopipam when administered with rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
T½ el of ecopipam when administered without rifampicin
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Secondary outcomes (63)
AUC0-inf of EBS-101-40853
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-inf of ecopipam glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-inf of EBS-101-40853 glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-t of EBS-101-40853
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-t of ecopipam glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-t of EBS-101-40853 glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Cmax of EBS-101-40853
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Cmax of ecopipam glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Cmax of EBS-101-40853 glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
T½ el of EBS-101-40853
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
T½ el of ecopipam glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
T½ el of EBS-101-40853 glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-4 for ecopipam
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-4 for EBS-101-40853
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-4 for ecopipam glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
AUC0-4 for EBS 101-40853 glucuronide
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 21
Minimum Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score
Score from 0-5 where 0 is no response and 5 is responds readily. MOAA/S measures will be recorded at the indicated timepoints
Measured: Up to Day 21
AUEC for Visual Analogue Scale (VAS)
Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints.
Measured: Up to Day 21
Maximum sedation for Visual Analogue Scale (VAS)
Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints.
Measured: Up to Day 21
AUEC for Reaction Time Index (RTI) score
Reaction time for subject to release the response button after presentation of target stimulus.
Measured: Up to Day 21
Maximum sedation for Reaction Time Index (RTI) score
Reaction time for subject to release the response button after presentation of target stimulus.
Measured: Up to Day 21
Safety and tolerability as demonstrated by AEs with itraconazole
Subjects will be continually monitored for adverse events
Measured: Up to Day 30
Safety and tolerability as demonstrated by AEs without itraconazole
Subjects will be continually monitored for adverse events
Measured: Up to Day 30
Safety and tolerability as demonstrated by AEs with rifampicin
Subjects will be continually monitored for adverse events
Measured: Up to Day 30
Safety and tolerability as demonstrated by AEs without rifampicin
Subjects will be continually monitored for adverse events
Measured: Up to Day 30
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with itraconazole (mmHG)
Blood pressure will be assessed as part of vital signs
Measured: Up to Day 21
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without itraconazole(mmHG)
Blood pressure will be assessed as part of vital signs
Measured: Up to Day 21
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with rifampicin(mmHG)
Blood pressure will be assessed as part of vital signs
Measured: Up to Day 21
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without rifampicin(mmHG)
Blood pressure will be assessed as part of vital signs
Measured: Up to Day 21
Heart rate with itraconazole (beats/minute)
Heart rate will be assessed as part of vital signs
Measured: Up to Day 21
Heart rate without itraconazole (beats/minute)
Heart rate will be assessed as part of vital signs
Measured: Up to Day 21
Heart rate with rifampicin (beats/minute)
Heart rate will be assessed as part of vital signs
Measured: Up to Day 21
Heart rate without rifampicin (beats/minute)
Heart rate will be assessed as part of vital signs
Measured: Up to Day 21
Respiratory rate pressure with itraconazole (breaths/minute)
Respiratory rate will be assessed as part of vital signs
Measured: Up to Day 21
Respiratory rate without itraconazole (breaths/minute)
Respiratory rate will be assessed as part of vital signs
Measured: Up to Day 21
Respiratory rate with rifampicin (breaths/minute)
Respiratory rate will be assessed as part of vital signs
Measured: Up to Day 21
Respiratory rate without rifampicin (breaths/minute)
Respiratory rate will be assessed as part of vital signs
Measured: Up to Day 21
Oral temperature with itraconazole (degrees Celsius)
Temperature will be assessed as part of vital signs
Measured: Up to Day 21
Oral temperature without itraconazole (degrees Celsius)
Temperature will be assessed as part of vital signs
Measured: Up to Day 21
Oral temperature with rifampicin (degrees Celsius)
Temperature will be assessed as part of vital signs
Measured: Up to Day 21
Oral temperature without rifampicin (degrees Celsius)
Temperature will be assessed as part of vital signs
Measured: Up to Day 21
Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with itraconazole (Milliseconds)
Twelve-lead ECGs will be obtained at the indicated timepoints
Measured: Up to Day 21
Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without itraconazole (Milliseconds)
Twelve-lead ECGs will be obtained at the indicated timepoints
Measured: Up to Day 21
Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with rifampicin (Milliseconds)
Twelve-lead ECGs will be obtained at the indicated timepoints
Measured: Up to Day 21
Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without rifampicin (Milliseconds)
Twelve-lead ECGs will be obtained at the indicated timepoints
Measured: Up to Day 21
Safety and tolerability as demonstrated by the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS to be administered at the indicated timepoints
Measured: Up to Day 21
Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 21
Value of hematocrit (percent)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 21
Value of hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 21
Red blood cell (RBC) count (M/mm3)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 21
Values of sodium, potassium, chloride (mmol/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 21
Values of urea, phosphorus, calcium, glucose, and total, direct and indirect bilirubin (mg/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 21
Values of albumin and total protein (g/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 21
Values of alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatininephosphokinase (CPK), and creatinine (U/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 21
Values of urine specific gravity
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urine pH
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urine glucose
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urine protein
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urine blood
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urine ketones
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urine bilirubin and nitrite
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urobilinogen
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Values of urine leukocyte esterase by dipstick
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start18 Jan 2024
- Primary completion14 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Cambridge Cognition Ltd
- Responsible party
- Sponsor
- Investigators
- Rick Munschauer, MSc, MD, FAAN, Study director, Emalex Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194864
- Sponsor's protocol ID
- EBS-101-HV-106
- Status last verified
- Sep 2024
- First submitted
- 22 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Sequential Drug Interaction Study to Evaluate the Effect of CYP3A4 and P-glycoprotein Inhibition by Itraconazole or Induction by Rifampicin on the Pharmacokinetics of Ecopipam and Its Metabolites in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06194864
- Acronym / sponsor ID
- EBS-101-HV-106
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Cambridge Cognition Ltd
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 8 Jan 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.
This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Itraconazole, Drug: Ecopipamecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16. |
| Part 2 | Experimental | Drug: rifampicin, Drug: Ecopipamecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male subjects or femail 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 (17 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 7 days 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 |
|---|---|---|
| Itraconazoleitraconazole 200 mg QD Days 6 to 16 | Drug | Part 1 |
| rifampicinrifampicin 600 mg QD Days 6 to 20 | Drug | Part 2 |
| Ecopipam89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2 | Drug | Part 1, Part 2 |
Primary outcome
AUC0-inf of ecopipam when administered with itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-inf of ecopipam when administered without itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-inf of ecopipam when administered with rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-inf of ecopipam when administered without rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-t of ecopipam when administered with itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-t of ecopipam when administered without itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-t of ecopipam when administered with rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-t of ecopipam when administered without rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam when administered with itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam when administered without itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam when administered with rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam when administered without rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
T½ el of ecopipam when administered with itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
T½ el of ecopipam when administered without itraconazole
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
T½ el of ecopipam when administered with rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
T½ el of ecopipam when administered without rifampicin
Time frame: Up to Day 21
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
63 secondary outcomes
AUC0-inf of EBS-101-40853
Time frame: Up to Day 21
AUC0-inf of ecopipam glucuronide
Time frame: Up to Day 21
AUC0-inf of EBS-101-40853 glucuronide
Time frame: Up to Day 21
AUC0-t of EBS-101-40853
Time frame: Up to Day 21
AUC0-t of ecopipam glucuronide
Time frame: Up to Day 21
AUC0-t of EBS-101-40853 glucuronide
Time frame: Up to Day 21
Cmax of EBS-101-40853
Time frame: Up to Day 21
Cmax of ecopipam glucuronide
Time frame: Up to Day 21
Cmax of EBS-101-40853 glucuronide
Time frame: Up to Day 21
T½ el of EBS-101-40853
Time frame: Up to Day 21
T½ el of ecopipam glucuronide
Time frame: Up to Day 21
T½ el of EBS-101-40853 glucuronide
Time frame: Up to Day 21
AUC0-4 for ecopipam
Time frame: Up to Day 21
AUC0-4 for EBS-101-40853
Time frame: Up to Day 21
AUC0-4 for ecopipam glucuronide
Time frame: Up to Day 21
AUC0-4 for EBS 101-40853 glucuronide
Time frame: Up to Day 21
Minimum Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score
Time frame: Up to Day 21
AUEC for Visual Analogue Scale (VAS)
Time frame: Up to Day 21
Maximum sedation for Visual Analogue Scale (VAS)
Time frame: Up to Day 21
AUEC for Reaction Time Index (RTI) score
Time frame: Up to Day 21
Maximum sedation for Reaction Time Index (RTI) score
Time frame: Up to Day 21
Safety and tolerability as demonstrated by AEs with itraconazole
Time frame: Up to Day 30
Safety and tolerability as demonstrated by AEs without itraconazole
Time frame: Up to Day 30
Safety and tolerability as demonstrated by AEs with rifampicin
Time frame: Up to Day 30
Safety and tolerability as demonstrated by AEs without rifampicin
Time frame: Up to Day 30
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with itraconazole (mmHG)
Time frame: Up to Day 21
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without itraconazole(mmHG)
Time frame: Up to Day 21
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with rifampicin(mmHG)
Time frame: Up to Day 21
Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without rifampicin(mmHG)
Time frame: Up to Day 21
Heart rate with itraconazole (beats/minute)
Time frame: Up to Day 21
Heart rate without itraconazole (beats/minute)
Time frame: Up to Day 21
Heart rate with rifampicin (beats/minute)
Time frame: Up to Day 21
Heart rate without rifampicin (beats/minute)
Time frame: Up to Day 21
Respiratory rate pressure with itraconazole (breaths/minute)
Time frame: Up to Day 21
Respiratory rate without itraconazole (breaths/minute)
Time frame: Up to Day 21
Respiratory rate with rifampicin (breaths/minute)
Time frame: Up to Day 21
Respiratory rate without rifampicin (breaths/minute)
Time frame: Up to Day 21
Oral temperature with itraconazole (degrees Celsius)
Time frame: Up to Day 21
Oral temperature without itraconazole (degrees Celsius)
Time frame: Up to Day 21
Oral temperature with rifampicin (degrees Celsius)
Time frame: Up to Day 21
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 Sep 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.
Rick Munschauer, MSc, MD, FAAN study director
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 Itraconazole, rifampicin and Ecopipam in people with Drug Interaction, run by Emalex Biosciences Inc. at 1 site in Canada.
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 7 inclusion and 17 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 Sep 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 Canada. 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?
AUC0-inf of ecopipam when administered with itraconazole (time frame: Up to Day 21). The study lists 16 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 19 Sep 2024.