CompletedNCT05841160Updated Jun 9, 2023

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

A Phase 1 interventional study of Ecopipam Hydrochloride and Moxifloxacin in QT/QTc, sponsored by Emalex Biosciences Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-09.

Sponsored by Emalex Biosciences Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was May 2023, 3 years 5 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 29
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the 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 studied

QT/QTc

In context

Lead sponsor

Emalex Biosciences Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 29 participants (actual)

Study arms

Experimental
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
Drug: Ecopipam Hydrochloride · Drug: Placebo
Experimental
600 mg ecopipam HCL
Single 600 mg dose of ecopipam HCL given as 6 x 100 mg ecopipam HCL oral tablets
Drug: Ecopipam Hydrochloride
Active comparator
400 mg moxifloxacin
Single 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet
Drug: Moxifloxacin
Placebo comparator
Placebo
Single oral dose of 6 x placebo tablets
Drug: Placebo

Interventions

DrugEcopipam Hydrochloride
oral tablets
DrugMoxifloxacin
oral tablet
DrugPlacebo
oral tablet

What researchers measure

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
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
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of ecopipam after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of ecopipam after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of ecopipam after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of ecopipam after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of ecopipam after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of ecopipam after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of ecopipam after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of ecopipam after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of ecopipam after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of ecopipam after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of ecopipam after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of ecopipam after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of ecopipam after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of EBS-101-40853 after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of EBS-101-40853 after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of EBS-101-40853 after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of EBS-101-40853 after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of EBS-101-40853 after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of EBS-101-40853 after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of EBS-101-40853 after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of EBS-101-40853 after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of EBS-101-40853 after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of EBS-101-40853 after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of EBS-101-40853 after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of EBS-101-40853 after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of EBS-101-40853 after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of EBS-101-40853 after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of ecopipam glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of ecopipam glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of ecopipam glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of ecopipam glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of ecopipam glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of ecopipam glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of ecopipam glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of ecopipam glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of ecopipam glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of ecopipam glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of ecopipam glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of ecopipam glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Cmax of moxifloxacin after a single dose of moxifloxacin 400 mg
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the Tmax of moxifloxacin after a single dose of moxifloxacin 400 mg
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUClast of moxifloxacin after a single dose of moxifloxacin 400 mg
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCinf of moxifloxacin after a single dose of moxifloxacin 400 mg
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the AUCext of moxifloxacin after a single dose of moxifloxacin 400 mg
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the λz of moxifloxacin after a single dose of moxifloxacin 400 mg
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33
Describe the t1/2 of moxifloxacin after a single dose of moxifloxacin 400 mg
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Time frame: Up to Day 33

Study locations

1 site

PPD Austin Phase 1 Clinical Research Unit
Austin, Texas 78744, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05841160
Lead sponsor: Emalex Biosciences Inc.
Collaborators: PPD DEVELOPMENT, LP, Clario
Responsible party: Sponsor
First posted: May 3, 2023
Start date: Mar 15, 2023
Primary completion: May 7, 2023
Completion: May 12, 2023
Last update: Jun 9, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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