Food-effect
Conditions
Brief 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.
Interventions
DRUGEcopipam tablet
A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)
Sponsors
Emalex Biosciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state | 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 fed state | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Safety and tolerability as demonstrated by concomitant medications | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Safety and tolerability as demonstrated by physical exams | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Safety and tolerability as demonstrated by AEs | Up to Day 20 | Subjects will be continually monitored for adverse events |
| Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Respiratory rate (breaths/minute) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Oral temperature (degrees Celsius) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Value of hematocrit (percent) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Red blood cell (RBC) count (M/mm3) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Values of urea, phosphorus, calcium, glucose, total cholesterol, HDL, LDL, triglycerides, uric acid, and total, direct and indirect bilirubin (mg/dL) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Values of albumin and total protein (g/dL) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Values of amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), creatine phosphokinase (CPK), and creatinine (U/L) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Value of urine pH | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Value of urine glucose | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Value of urine protein | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Value of urine blood | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Value of urine leukocyte esterase by dipstick | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Value of hemoglobin (g/dL) | Up to Day 20 | Safety and tolerability measures will be recorded at the indicated timepoints |
| Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to Day 13 | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
Countries
United States
Outcome results
None listed