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

NCT05841160 | Completed Phase 1 FDA Drug

• 1 other identifier: EBS-101-HV-105
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

QT/QTc

Outcome Measures

Primary Outcomes (1)

• 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 (78)

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

  Up to Day 25

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

  Up to Day 25

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

  Up to Day 25

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

  Up to Day 25

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

  Up to Day 25

Study Arms (4)

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

Interventions

Ecopipam Hydrochloride DRUG

oral tablets

200 mg ecopipam HCL; 600 mg ecopipam HCL

Moxifloxacin DRUG

oral tablet

400 mg moxifloxacin

Placebo DRUG

oral tablet

200 mg ecopipam HCL; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female of nonchildbearing potential
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead
• PPD Development, LP: collaborator
• Clario: collaborator

Study Sites (1)

PPD Austin Phase 1 Clinical Research Unit

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 3, 2023
• Study Start: March 15, 2023
• Primary Completion: May 7, 2023
• Study Completion: May 12, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)