NCT05236868已完成1 期
An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-42847922 (Seltorexant) Administered as Oral Tablet and an Intravenous Microdose of 14C-seltorexant in Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Absolute Bioavailability
研究概览
简要总结
The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Healthy on the basis of medical history at screening and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site on Day 1
- •Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site on Day -1
- •All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1
- •A woman must be a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 3 months after the study treatment administration
- •Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
排除标准
- •Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study site (Day -1) as determined by the investigator. Alanine transaminase (ALT)/aspartate transaminase (AST) concentrations within normal range at screening. One retest for ALT/AST is permitted
- •Clinically significant abnormal physical examination, vital signs, or 12-lead (ECG) at screening or at admission to the study site on Day -1 as determined by the investigator
- •Participant has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia-Suicide Severity Rating Scale (C SSRS), or a lifetime history of suicidal behavior or suicidal attempt as validated by the C SSRS at screening
- •Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
- •Has any history or current diagnosis of obstructive sleep apnea or parasomnias. Participants with restless leg syndrome/periodic leg movement disorder or insomnia disorder are allowed if not requiring medication
研究组 & 干预措施
Seltorexant
Experimental
Participants will receive a single oral dose of seltorexant. At 2 hours after oral dosing, participants will receive 14C-seltorexant as an intravenous (IV) infusion over 15 minutes.
干预措施: Seltorexant (Drug)
结局指标
主要结局
Absolute Bioavailability
时间窗: Up to Day 4
Absolute bioavailability is calculated as the ratio of dose normalized area under the plasma drug concentration-time curve (AUC) of oral and intravenous (IV) administration.
次要结局
- Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Infinite time (AUC [0-Infinity])(Up to Day 4)
- Apparent Terminal Elimination Half-life (t1/2) of Seltorexant(Up to Day 4)
- Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])(Up to Day 4)
- Maximum Observed Plasma Analyte Concentration (Cmax) of Seltorexant(Up to Day 4)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Seltorexant(Up to Day 4)
- Number of Participants with Adverse Events (AEs)(Screening (up to -21 days) up to Day 7)
研究者
研究点 (1)
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