Food-effect Study of Ecopipam Pharmacokinetics

NCT ID: NCT06669091

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2024-12-27

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.

Conditions

Food-effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dosed in fasted state

Ecopipam will be taken in the morning in a fasted state

Group Type: OTHER

Ecopipam tablet

Intervention Type: DRUG

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

Dosed in fed state

Ecopipam will be taken in the morning after a standard high-fat breakfast

Group Type: OTHER

Ecopipam tablet

Intervention Type: DRUG

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

Interventions

Ecopipam tablet

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emalex Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick Munschauer, MSc, MD, FAAN

Role: STUDY_CHAIR

Emalex Biosciences

Locations

ICON Early Phase Services

San Antonio, Texas, United States

Countries

United States

Other Identifiers

EBS-101-HV-107

Identifier Type: -

Identifier Source: org_study_id