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

Emalex Biosciences Inc.29 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

QT/QTc

Interventions

Ecopipam HydrochlorideDRUG

oral tablets

MoxifloxacinDRUG

oral tablet

PlaceboDRUG

oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PPD Austin Phase 1 Clinical Research Unit

Austin, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Up to Day 25

Secondary Outcomes

Evaluate the effect of ecopipam at a therapeutic dose on heart rate

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at a therapeutic dose on PR interval

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at a therapeutic dose on QRS interval

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at a therapeutic dose on T-wave morphology

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at a therapeutic dose on U wave presence

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at supratherapeutic dose on heart rate

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at supratherapeutic dose on PR interval

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at supratherapeutic dose on QRS interval

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at supratherapeutic dose on T-wave morphology

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effect of ecopipam at supratherapeutic dose on U wave presence

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the ECG assay sensitivity to detect a change in the QT interval corrected for heart rate using Fridericia's formula (QTcF interval) using 400 mg moxifloxacin as the positive control

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Evaluate the effects of ecopipam on the emergence of arrhythmias

ECGs will be collected for up to 48 hours after each dose

Time frame: Up to Day 25

Describe the incidence of treatment-emergent adverse events after a single therapeutic dose of ecopipam

AEs will be collected throughout the duration of the study

Time frame: Up to Day 33

Describe the incidence of treatment-emergent adverse events after a single supratherapeutic dose of ecopipam

AEs will be collected throughout the duration of the study

Time frame: Up to Day 33

Describe the incidence of treatment-emergent adverse events after a single dose of moxifloxacin 400 mg

AEs will be collected throughout the duration of the study

Time frame: Up to Day 33

Describe the Cmax of ecopipam after single therapeutic dose of ecopipam