Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05841160
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05841160
Study Brief:
Protocol Section:
NCT05841160