Food-effect Study of Ecopipam Pharmacokinetics

Emalex Biosciences

Status and phase: Completed; Phase 1

Conditions: Food-effect

Treatments: Drug: Ecopipam tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06669091

EBS-101-HV-107

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Dosed in fasted state

Other group

Description:

Ecopipam will be taken in the morning in a fasted state

Treatment:

Drug: Ecopipam tablet

Dosed in fed state

Other group

Description:

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

Treatment:

Drug: Ecopipam tablet