Food-effect Study of Ecopipam Pharmacokinetics

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.

Study Overview

• Status: Completed
• Conditions: Food-effect
• Intervention / Treatment: Drug: Ecopipam tablet

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Early Phase Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dosed in fasted state; Ecopipam will be taken in the morning in a fasted state	Drug: Ecopipam tablet; A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)
Other: Dosed in fed state; Ecopipam will be taken in the morning after a standard high-fat breakfast	Drug: Ecopipam tablet; A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	Up to Day 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Up to Day 13
Safety and tolerability as demonstrated by concomitant medications	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Safety and tolerability as demonstrated by physical exams	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Safety and tolerability as demonstrated by AEs	Subjects will be continually monitored for adverse events	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	Up to Day 20
Respiratory rate (breaths/minute)	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Oral temperature (degrees Celsius)	Safety and tolerability measures will be recorded at the indicated timepoints	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	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	Up to Day 20
Value of hematocrit (percent)	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Value of hemoglobin (g/dL)	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Red blood cell (RBC) count (M/mm3)	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L)	Safety and tolerability measures will be recorded at the indicated timepoints	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	Up to Day 20
Values of albumin and total protein (g/dL)	Safety and tolerability measures will be recorded at the indicated timepoints	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	Up to Day 20
Value of urine pH	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Value of urine glucose	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Value of urine protein	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Value of urine blood	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20
Value of urine leukocyte esterase by dipstick	Safety and tolerability measures will be recorded at the indicated timepoints	Up to Day 20

Collaborators and Investigators

• Sponsor: Emalex Biosciences Inc.
• Investigators: Study Chair: Frederick Munschauer, MSc, MD, FAAN, Emalex Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): December 22, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Antipsychotic Agents; Dopamine Antagonists; Ecopipam
• Other Study ID Numbers: EBS-101-HV-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No