Drug Interaction Study

Emalex Biosciences

Status and phase: Completed; Phase 1

Conditions: Drug Interaction

Treatments: Drug: Ecopipam; Drug: Itraconazole; Drug: rifampicin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06194864

EBS-101-HV-106

Details and patient eligibility

About

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male subjects or femail 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.
• Willing to take off dentures or mouth piercing at the time of dosing.

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 7 days 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
• Female subjects who are currently pregnant or lactating
• Positive pregnancy test
• Positive urine drug screen, urine cotinine test, or alcohol breath test
• Use of tobacco or nicotine products within 1 month prior to Screening
• Significant alcohol consumption
• History of drug abuse within the previous year, or a positive drug screen
• History of allergy to study medications
• Part 1 only: Presence of orthodontic braces or orthodontic retention wires
• Recent participation in a clinical research study
• Not suitable for study in the opinion of the Principal Investigator

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Part 1

Experimental group

Description:

ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16.

Treatment:

Drug: Itraconazole

Drug: Ecopipam

Part 2

Experimental group

Description:

ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20.

Treatment:

Drug: rifampicin

Drug: Ecopipam