PPD Austin Phase 1 Clinical Research Unit
Austin, Texas, 78744, United States
Completed
NCT Number: NCT05841160
Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization
THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Ecopipam Hydrochloride
Drugoral tablets
moxifloxacin
Drugoral tablet
Placebo
Drugoral tablet
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.
Time frame: Up to Day 25
ECGs and PK samples will be collected for up to 96 hours after each dose
Secondary outcomes
-
Evaluate the effect of ecopipam at a therapeutic dose on heart rate
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at a therapeutic dose on PR interval
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at a therapeutic dose on QRS interval
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at a therapeutic dose on T-wave morphology
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at a therapeutic dose on U wave presence
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at supratherapeutic dose on heart rate
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at supratherapeutic dose on PR interval
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at supratherapeutic dose on QRS interval
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at supratherapeutic dose on T-wave morphology
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effect of ecopipam at supratherapeutic dose on U wave presence
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
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
ECGs will be collected for up to 48 hours after each dose
-
Evaluate the effects of ecopipam on the emergence of arrhythmias
Time frame: Up to Day 25
ECGs will be collected for up to 48 hours after each dose
-
Describe the incidence of treatment-emergent adverse events after a single therapeutic dose of ecopipam
Time frame: Up to Day 33
AEs will be collected throughout the duration of the study
-
Describe the incidence of treatment-emergent adverse events after a single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
AEs will be collected throughout the duration of the study
-
Describe the incidence of treatment-emergent adverse events after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
AEs will be collected throughout the duration of the study
-
Describe the Cmax of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of ecopipam after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of ecopipam after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of EBS-101-40853 after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of EBS-101-40853 after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of ecopipam glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of ecopipam glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of ecopipam glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of ecopipam glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of ecopipam glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of ecopipam glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of ecopipam glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of ecopipam glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of ecopipam glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of ecopipam glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of ecopipam glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of ecopipam glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Cmax of moxifloxacin after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the Tmax of moxifloxacin after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUClast of moxifloxacin after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCinf of moxifloxacin after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the AUCext of moxifloxacin after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the λz of moxifloxacin after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
-
Describe the t1/2 of moxifloxacin after a single dose of moxifloxacin 400 mg
Time frame: Up to Day 33
17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis
Sponsors and collaborators
Lead sponsor
Emalex Biosciences Inc.
Industry
Collaborators
- Clario
- PPD Development, LP
Registry information
Official study 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
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- May 3, 2023
- Registry last updated
- Jun 9, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.