Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization (NCT05841160) | Clinical Trial Compass
CompletedPhase 1
Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization
United States29 participantsStarted 2023-03-15
Plain-language summary
THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION
Who can participate
Age range18 Years – 55 Years
SexALL
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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 p…
What they're measuring
1
Evaluate ecopipam's effect on the QTc interval after administration of therapeutic and supratherapeutic doses, compared to placebo as a negative control using C-QTc analysis.