Thorough QT/QTc Study to Evaluate the Effects of Ecopipam... | NCT05841160

NCT05841160

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
PPD Development, LP	INDUSTRY
Clario	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
200 mg ecopipam HCL	Experimental	Single 200 mg dose of ecopipam HCL given as 2 x 100 mg ecopipam HCL oral tablets and 4 placebo oral tablets	Drug: Ecopipam Hydrochloride Drug: Placebo
600 mg ecopipam HCL	Experimental	Single 600 mg dose of ecopipam HCL given as 6 x 100 mg ecopipam HCL oral tablets	Drug: Ecopipam Hydrochloride
400 mg moxifloxacin	Active Comparator	Single 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet	Drug: Moxifloxacin
Placebo	Placebo Comparator	Single oral dose of 6 x placebo tablets	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ecopipam Hydrochloride	Drug	oral tablets	200 mg ecopipam HCL 600 mg ecopipam HCL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	ECGs and PK samples will be collected for up to 96 hours after each dose	Up to Day 25

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the effect of ecopipam at a therapeutic dose on heart rate	ECGs will be collected for up to 48 hours after each dose	Up to Day 25
Evaluate the effect of ecopipam at a therapeutic dose on PR interval

Eligibility Module

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.

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines