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

Emalex Biosciences

Status and phase: Completed; Phase 1

Conditions: QT/QTc

Treatments: Drug: Moxifloxacin; Drug: Placebo; Drug: Ecopipam Hydrochloride

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05841160

EBS-101-HV-105

Details and patient eligibility

About

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

Full description

This is a single-center, randomized, partially double-blind (open-label moxifloxacin), placebo- and positive-controlled, 4-way crossover study in healthy subjects. Following a 28 day screening period, eligible subjects will enter the clinical research unit (CRU) on Day -1. A total of 32 subjects will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment sequences (8 subjects per treatment sequence). Subjects will receive the assigned study drug as a single oral dose in the morning on Day 1 of each treatment period (Day 1 [Period 1], Day 8 [Period 2], Day 15 [Period 3], and Day 22 [Period 4]) after an overnight fast. Subjects will have serially matched blood samples (for determination of plasma concentrations) and 12-lead ECGs collected at predose and up to 48 hours after each dose for C QTc analysis. Subjects will be discharged from the CRU 96 hours after the last dose of the study drug (Day 26). A follow-up telephone call will occur 5 ±2 days after discharge (Day 31 ±2).

Enrollment: 29 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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29 participants in 4 patient groups, including a placebo group

200 mg ecopipam HCL

Experimental group

Description:

Single 200 mg dose of ecopipam HCL given as 2 x 100 mg ecopipam HCL oral tablets and 4 placebo oral tablets

Treatment:

Drug: Ecopipam Hydrochloride

Drug: Placebo

600 mg ecopipam HCL

Experimental group

Description:

Single 600 mg dose of ecopipam HCL given as 6 x 100 mg ecopipam HCL oral tablets

Treatment:

Drug: Ecopipam Hydrochloride

400 mg moxifloxacin

Active Comparator group

Description:

Single 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet

Treatment:

Drug: Moxifloxacin

Placebo

Placebo Comparator group

Description:

Single oral dose of 6 x placebo tablets

Treatment:

Drug: Placebo