Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization

• Status: Recruiting
• Trial end date: 2023-07-02
• Target enrollment: 0
• Participant gender: All

Summary

THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emalex Biosciences Inc.
• Collaborators: Clario; PPD
• Treatments: Ecopipam; Moxifloxacin

Criteria

Inclusion Criteria:

• Male or female of nonchildbearing potential

• 18 to 55 years of age

• BMI of 18 to 30 kg/m2, and weight of at least 50 kg for males and 45 kg for females.

• Subject considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and PE findings.

• Male subjects with female partners of childbearing potential must agree to use a double-barrier method of contraception during the study and agree to continue the use of male contraception for at least 90 days after the last dose of study drug.

• Male subjects must be willing to refrain from donating sperm during study participation and for 90 days after the last dose of study drug.

• The subject is able to provide written informed consent and agrees to comply with all protocol requirements.

Exclusion Criteria:

• Female subjects of childbearing potential or who are currently pregnant or lactating

• Subjects with a history of significant medical illness

• Clinically significant abnormalities on screening tests/exams

• History of or serious risk of committing suicide

• Donation of plasma within 7 days prior to dosing

• Donation of significant loss of blood within 30 days prior to dosing

• Major surgery within 3 months or minor surgery within 1 month prior to CRU admission

• Use of prohibited prescription, over-the-counter medications or natural health products

• Alcohol-based products within 24 hours prior to check-in on Day -1

• Vaccinations within 72 hours prior to check-in on Day -1

• Subjects with a history of any clinically significant ECG or vital sign abnormalities or presence of any clinically significant ECG or vital sign abnormalities or changes at screening or on Day -1

• Positive test result for drugs of abuse, alcohol, or cotinine

• Use of nicotine or nicotine-containing products within 90 days before the first dose of study drug.

• Subjects with a history of excessive alcohol intake or abuse or drug addiction within the last year

• Subjects with a history of allergy, allergic skin rash, asthma, or an intolerance, sensitivity, or photosensitivity to moxifloxacin or ecopipam

• Subjects who have participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dose or administration of a biological product in the context of a clinical research study within 90 days prior to the first dose

• Subjects with prior exposure to ecopipam

• Any subject who, in the opinion of the investigator, is not a suitable candidate for the study.