A Phase 1, Open-label, Single-sequence Pharmacokinetic Trial to Assess the Effect of a Single Oral Dose of SEP-380135 on the Potential for Cytochrome P4502D6 Mediated Drug-drug Interactions in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites
研究概览
简要总结
The purpose of this study is to assess the effect of cytochrome P450 isoenzyme 2D6 (CYP2D6) inhibition by quinidine on the pharmacokinetic (PK) parameters of a single dose SEP-380135 in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 participants between 18 and 55 years of age (inclusive) at time of consent
- •Body mass index from 18.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
- •In good health as determined by:
- •Medical history
- •Physical examination
- •Vital signs
- •Neurological examination
- •Electrocardiogram
- •Serum chemistry, lipid panel, thyroid panel, coagulation panel, urinalysis, hematology, and serology tests (from screening visit).
- •Willing to stay in the clinic for the required period (i.e., to be hospitalized for 10 days) and willing to be contacted for the safety follow-up telephone call.
- •Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the trial.
排除标准
- •Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
- •Have had previous exposure to SEP-
- •Are currently participating in another clinical trial.
- •Attempted suicide within 12 months prior to screening.
- •A history of sick sinus syndrome, first-, second-, or third-degree atrioventricular block, myocardial infarction, New York Heart Association Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.
- •In the opinion of the investigator, should not participate in the trial.
- •Note: Other protocol-specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
SEP-380135 + Quinidine Gluconate
Participants receive SEP-380135 alone on Day 1, followed by administration of quinidine gluconate beginning on Day 6. On Day 7, SEP-380135 is coadministered with quinidine gluconate. Quinidine gluconate dosing continues from Day 8 to Day 10.
干预措施: SEP-380135 (Drug)
SEP-380135 + Quinidine Gluconate
Participants receive SEP-380135 alone on Day 1, followed by administration of quinidine gluconate beginning on Day 6. On Day 7, SEP-380135 is coadministered with quinidine gluconate. Quinidine gluconate dosing continues from Day 8 to Day 10.
干预措施: Quinidine Gluconate (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites
时间窗: Up to Day 11
Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites
时间窗: Up to Day 11
Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites
时间窗: Up to Day 11
Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites
时间窗: Up to Day 11
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to 2 months)
- Number of Participants With Potentially Clinically Significant Changes in Vital Signs(Up to 2 months)
- Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters(Up to 2 months)
- Number of Participants With Potentially Clinically Significant Changes in Physical Examinations(Up to 2 months)
- Number of Participants With Potentially Clinically Significant Changes in Neurological Examinations(Up to 2 months)
- Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters(Up to 2 months)
- Number of Participants With Incidence of Suicidal Behavior, Suicidal Ideation and Suicidality Using the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 2 months)