QT/QTcPhase 1NCT05841160
Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization
A Phase 1 study testing Ecopipam Hydrochloride and Moxifloxacin in people with QT/QTc, run by Emalex Biosciences Inc. at 1 site in United States.
Trial summary
THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- QT/QTc
- What is being tested?
- Ecopipam Hydrochloride and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 12 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
PPD Austin Phase 1 Clinical Research Unit
Austin, Texas, 78744
About this study
Official title: A Randomized, Double-Blind, Placebo- and Positive Controlled, Crossover, Thorough QT/QTc Study to Evaluate the Effects of a Therapeutic and Supratherapeutic Dose of Ecopipam (EBS-101) on Cardiac Repolarization in Healthy Subjects
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
- QT/QTc
- Being tested
- Ecopipam Hydrochloride, Moxifloxacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecopipam HydrochlorideDrug
oral tablets
MoxifloxacinDrug
oral tablet
PlaceboDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ecopipam Hydrochloride |
| 400 mg moxifloxacin | Active comparator | Single 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet Receives: Drug: Moxifloxacin |
| Placebo | Placebo comparator | Single oral dose of 6 x placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 25
Secondary outcomes (78)
Evaluate the effect of ecopipam at a therapeutic dose on heart rate
ECGs will be collected for up to 48 hours after each dose
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start15 Mar 2023
- Primary completion7 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QT/QTcStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Clario
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841160
- Sponsor's protocol ID
- EBS-101-HV-105
- Status last verified
- Jun 2023
- First submitted
- 10 Apr 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Positive Controlled, Crossover, Thorough QT/QTc Study to Evaluate the Effects of a Therapeutic and Supratherapeutic Dose of Ecopipam (EBS-101) on Cardiac Repolarization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05841160
- Acronym / sponsor ID
- EBS-101-HV-105
- Conditions
- QT/QTc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Clario
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 7 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200 mg ecopipam HCL | Experimental | Drug: Ecopipam Hydrochloride, Drug: PlaceboSingle 200 mg dose of ecopipam HCL given as 2 x 100 mg ecopipam HCL oral tablets and 4 placebo oral tablets |
| 600 mg ecopipam HCL | Experimental | Drug: Ecopipam HydrochlorideSingle 600 mg dose of ecopipam HCL given as 6 x 100 mg ecopipam HCL oral tablets |
| 400 mg moxifloxacin | Active comparator | Drug: MoxifloxacinSingle 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet |
| Placebo | Placebo comparator | Drug: PlaceboSingle oral dose of 6 x placebo tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecopipam Hydrochlorideoral tablets | Drug | 200 mg ecopipam HCL, 600 mg ecopipam HCL |
| Moxifloxacinoral tablet | Drug | 400 mg moxifloxacin |
| Placebooral tablet | Drug | 200 mg ecopipam HCL, Placebo |
Primary outcome
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.
Time frame: Up to Day 25
ECGs and PK samples will be collected for up to 96 hours after each dose
78 secondary outcomes
Evaluate the effect of ecopipam at a therapeutic dose on heart rate
Time frame: Up to Day 25
Evaluate the effect of ecopipam at a therapeutic dose on PR interval
Time frame: Up to Day 25
Evaluate the effect of ecopipam at a therapeutic dose on QRS interval
Time frame: Up to Day 25
Evaluate the effect of ecopipam at a therapeutic dose on T-wave morphology
Time frame: Up to Day 25
Evaluate the effect of ecopipam at a therapeutic dose on U wave presence
Time frame: Up to Day 25
Evaluate the effect of ecopipam at supratherapeutic dose on heart rate
Time frame: Up to Day 25
Evaluate the effect of ecopipam at supratherapeutic dose on PR interval
Time frame: Up to Day 25
Evaluate the effect of ecopipam at supratherapeutic dose on QRS interval
Time frame: Up to Day 25
Evaluate the effect of ecopipam at supratherapeutic dose on T-wave morphology
Time frame: Up to Day 25
Evaluate the effect of ecopipam at supratherapeutic dose on U wave presence
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
Time frame: Up to Day 25
Evaluate the effects of ecopipam on the emergence of arrhythmias
Time frame: Up to Day 25
Describe the incidence of treatment-emergent adverse events after a single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the incidence of treatment-emergent adverse events after a single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the incidence of treatment-emergent adverse events after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
Describe the Cmax of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the Tmax of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUClast of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUCinf of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUCext of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the λz of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the t1/2 of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the Cmax of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the Tmax of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUClast of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUCinf of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUCext of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the λz of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the t1/2 of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the Cmax of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the Tmax of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUClast of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUCinf of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUCext of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the λz of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the t1/2 of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the Cmax of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the Tmax of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUClast of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Describe the AUCinf of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ecopipam Hydrochloride and Moxifloxacin in people with QT/QTc, run by Emalex Biosciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to Day 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.