NCT05841160已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Ecopipam Hydrochloride (Drug)
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
干预措施: Placebo (Drug)
600 mg ecopipam HCL
Experimental
Single 600 mg dose of ecopipam HCL given as 6 x 100 mg ecopipam HCL oral tablets
干预措施: Ecopipam Hydrochloride (Drug)
400 mg moxifloxacin
Active Comparator
Single 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet
干预措施: Moxifloxacin (Drug)
Placebo
Placebo Comparator
Single oral dose of 6 x placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: Up to Day 25
ECGs and PK samples will be collected for up to 96 hours after each dose
次要结局
- Evaluate the effect of ecopipam at supratherapeutic dose on PR interval(Up to Day 25)
- 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)
- Describe the Tmax of ecopipam after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of ecopipam after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of ecopipam after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the λz of ecopipam after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of ecopipam after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of ecopipam after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Tmax of ecopipam after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of ecopipam after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of ecopipam after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of EBS-101-40853 after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of EBS-101-40853 after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of EBS-101-40853 after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Tmax of EBS-101-40853 after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of EBS-101-40853 after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Evaluate the effect of ecopipam at a therapeutic dose on T-wave morphology(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(Up to Day 25)
- Evaluate the effects of ecopipam on the emergence of arrhythmias(Up to Day 25)
- Describe the incidence of treatment-emergent adverse events after a single therapeutic dose of ecopipam(Up to Day 33)
- Describe the incidence of treatment-emergent adverse events after a single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the incidence of treatment-emergent adverse events after a single dose of moxifloxacin 400 mg(Up to Day 33)
- Describe the Cmax of ecopipam after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of ecopipam after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of EBS-101-40853 after single therapeutic dose of ecopipam(Up to Day 33)
- Evaluate the effect of ecopipam at a therapeutic dose on U wave presence(Up to Day 25)
- Evaluate the effect of ecopipam at supratherapeutic dose on heart rate(Up to Day 25)
- Evaluate the effect of ecopipam at supratherapeutic dose on QRS interval(Up to Day 25)
- Describe the λz of ecopipam after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Tmax of EBS-101-40853 after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of EBS-101-40853 after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of ecopipam glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Evaluate the effect of ecopipam at supratherapeutic dose on T-wave morphology(Up to Day 25)
- Evaluate the effect of ecopipam at supratherapeutic dose on U wave presence(Up to Day 25)
- Describe the λz of EBS-101-40853 after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the λz of EBS-101-40853 after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of ecopipam after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of ecopipam after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of EBS-101-40853 after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of EBS-101-40853 after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Tmax of ecopipam glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of EBS-101-40853 after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of EBS-101-40853 after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of ecopipam glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of ecopipam glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of ecopipam glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the λz of ecopipam glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of ecopipam glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of ecopipam glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of ecopipam glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of ecopipam glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the λz of ecopipam glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Tmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of ecopipam glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the Tmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the λz of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Tmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUClast of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCinf of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the AUCext of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the λz of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the t1/2 of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam(Up to Day 33)
- Describe the Cmax of moxifloxacin after a single dose of moxifloxacin 400 mg(Up to Day 33)
- Describe the Tmax of moxifloxacin after a single dose of moxifloxacin 400 mg(Up to Day 33)
- Describe the AUClast of moxifloxacin after a single dose of moxifloxacin 400 mg(Up to Day 33)
- Describe the AUCinf of moxifloxacin after a single dose of moxifloxacin 400 mg(Up to Day 33)
- Describe the AUCext of moxifloxacin after a single dose of moxifloxacin 400 mg(Up to Day 33)
- Describe the λz of moxifloxacin after a single dose of moxifloxacin 400 mg(Up to Day 33)
- Describe the t1/2 of moxifloxacin after a single dose of moxifloxacin 400 mg(Up to Day 33)
研究者
研究点 (1)
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