NCT06669091 - Food-effect Study of Ecopipam Pharmacokinetics | Crick | Crick

Food-effect Study of Ecopipam Pharmacokinetics

Phase 1CompletedNCT06669091

Emalex Biosciences Inc.25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

25

Conditions

Interventions

Ecopipam tabletDRUG

A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ICON Early Phase Services

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to Day 13

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to Day 13

Safety and tolerability as demonstrated by concomitant medications

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Safety and tolerability as demonstrated by physical exams

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Safety and tolerability as demonstrated by AEs

Subjects will be continually monitored for adverse events

Time frame: 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

Time frame: Up to Day 20

Respiratory rate (breaths/minute)

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Oral temperature (degrees Celsius)

Safety and tolerability measures will be recorded at the indicated timepoints

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)

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: 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

Time frame: Up to Day 20

Value of hematocrit (percent)

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Value of hemoglobin (g/dL)

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Red blood cell (RBC) count (M/mm3)

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L)

Safety and tolerability measures will be recorded at the indicated timepoints

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)

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Values of albumin and total protein (g/dL)

Safety and tolerability measures will be recorded at the indicated timepoints

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)

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Value of urine pH

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Value of urine glucose

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Value of urine protein

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Value of urine blood

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20

Value of urine leukocyte esterase by dipstick

Safety and tolerability measures will be recorded at the indicated timepoints

Time frame: Up to Day 20