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

NCT ID: NCT05841160

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-05-12

Brief Summary

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

Detailed 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).

Conditions

QT/QTc

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

200 mg ecopipam HCL

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

Group Type: EXPERIMENTAL

Ecopipam Hydrochloride

Intervention Type: DRUG

oral tablets

Placebo

Intervention Type: DRUG

oral tablet

600 mg ecopipam HCL

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

Group Type: EXPERIMENTAL

Ecopipam Hydrochloride

Intervention Type: DRUG

oral tablets

400 mg moxifloxacin

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

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

oral tablet

Placebo

Single oral dose of 6 x placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral tablet

Interventions

Ecopipam Hydrochloride

oral tablets

Intervention Type: DRUG

Moxifloxacin

oral tablet

Intervention Type: DRUG

Placebo

oral tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Clario

UNKNOWN

Sponsor Role: collaborator

Emalex Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Austin Phase 1 Clinical Research Unit

Austin, Texas, United States

Countries

United States

Other Identifiers

EBS-101-HV-105

Identifier Type: -

Identifier Source: org_study_id