Clinical trial NCT06669091: Food-effect Study of Ecopipam Pharmacokinetics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food-effect
Lead sponsor: Emalex Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax of ecopipam after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Tmax of ecopipam after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUC of ecopipam after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUCinf of ecopipam after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUClast of ecopipam after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Cmax of ecopipam after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: Tmax of ecopipam after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUC of ecopipam after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUClast of ecopipam after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
Secondary outcomes:
measure: Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state
timeFrame: Up to Day 13
measure: Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state
timeFrame: Up to Day 13
measure: Safety and tolerability as demonstrated by concomitant medications
timeFrame: Up to Day 20
measure: Safety and tolerability as demonstrated by physical exams
timeFrame: Up to Day 20
measure: Safety and tolerability as demonstrated by AEs
timeFrame: Up to Day 20
measure: Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
timeFrame: Up to Day 20
measure: Respiratory rate (breaths/minute)
timeFrame: Up to Day 20
measure: Oral temperature (degrees Celsius)
timeFrame: Up to Day 20
measure: Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)
timeFrame: Up to Day 20
measure: Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
timeFrame: Up to Day 20
measure: Value of hematocrit (percent)
timeFrame: Up to Day 20
measure: Value of hemoglobin (g/dL)
timeFrame: Up to Day 20
measure: Red blood cell (RBC) count (M/mm3)
timeFrame: Up to Day 20
measure: Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L)
timeFrame: Up to Day 20
measure: Values of urea, phosphorus, calcium, glucose, total cholesterol, HDL, LDL, triglycerides, uric acid, and total, direct and indirect bilirubin (mg/dL)
timeFrame: Up to Day 20
measure: Values of albumin and total protein (g/dL)
timeFrame: Up to Day 20
measure: Values of amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), creatine phosphokinase (CPK), and creatinine (U/L)
timeFrame: Up to Day 20
measure: Value of urine pH
timeFrame: Up to Day 20
measure: Value of urine glucose
timeFrame: Up to Day 20
measure: Value of urine protein
timeFrame: Up to Day 20
measure: Value of urine blood
timeFrame: Up to Day 20
measure: Value of urine leukocyte esterase by dipstick
timeFrame: Up to Day 20
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: Emalex Biosciences
name: Frederick Munschauer, MSc, MD, FAAN
role: STUDY_CHAIR
References: