A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence Between Different Formulations and Phase 3 Formulation of Seltorexant Under Fasted Conditions in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Seltorexant and its Metabolites
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalence of Test 1 and/or Test 2 seltorexant tablet formulations with respect to Reference seltorexant tablet formulation in healthy participants receiving a single dose under fasted conditions.
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
- 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
- •Be healthy on the basis of medical history (screening only), physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1 of Treatment Period 1 or prior to randomization
- •Be healthy on the basis of clinical laboratory tests performed at screening
- •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 of each treatment period
- •Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kilogram (kg)
- •Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
排除标准
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (estimated glomerular filtration rate [eGFR] less than (<) 80 milliliter per minute (mL/min)/1.73 per meter square (m^2) at screening only), thyroid disease, neurologic (including seizure disorders) or psychiatric disease (depression or anxiety disorder in remission and no longer requiring medication is acceptable), infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. Significant past gastrointestinal medical history, or any disease/surgery that would with interfere drug absorption
- •Has any significant or is suspected to have a primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias based on history and/or physical exam. Participants with insomnia disorder are allowed if not requiring medication
- •Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, oral contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
- •Known allergies, hypersensitivity, or intolerance to seltorexant or its excipients
- •Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C antibodies at screening
研究组 & 干预措施
Treatment Sequence ABC
Participants will receive a single dose of seltorexant as formulation (Test 1) (Treatment A) in Treatment Period 1, followed by a single dose of seltorexant as formulation (Test 2) (Treatment B) in Treatment Period 2, followed by a single dose of seltorexant as formulation (Reference) (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
干预措施: Seltorexant (Drug)
Treatment Sequence BCA
Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
干预措施: Seltorexant (Drug)
Treatment Sequence CAB
Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
干预措施: Seltorexant (Drug)
Treatment Sequence CBA
Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
干预措施: Seltorexant (Drug)
Treatment Sequence ACB
Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
干预措施: Seltorexant (Drug)
Treatment Sequence BAC
Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
干预措施: Seltorexant (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Seltorexant and its Metabolites
时间窗: Predose, up to 48 hours post dose (Day 3)
AUC (0-infinity) is defined as area under the plasma concentration-time curve of seltorexant and its metabolites extrapolated to infinity, calculated using the linear trapezoidal method from time zero to infinite time calculated as the sum of AUC(0-last)+C(last)/ lambda(z).
Maximum Observed Plasma Concentration (Cmax) of Seltorexant and its Metabolites
时间窗: Predose, up to 48 hours post dose (Day 3)
Cmax is defined as the maximum observed plasma concentration of seltorexant and its metabolites.
Last Observed Measurable Plasma Concentration (Clast) of Seltorexant and its Metabolites
时间窗: Predose, up to 48 hours post dose (Day 3)
Clast is defined as the last observed measurable (non-below quantification limit \[non-BQL\]) plasma concentration of seltorexant and its metabolites.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Seltorexant and its Metabolites
时间窗: Predose, up to 48 hours post dose (Day 3)
Tmax is defined as the actual sampling time to reach the maximum observed plasma concentration of seltorexant and its metabolites.
Area Under the Concentration-time Curve From Time Zero to Time of the Last Measurable Plasma Concentration (AUC [0-last]) of Seltorexant and its Metabolites
时间窗: Predose, up to 48 hours post dose (Day 3)
AUC (0-last) is defined as area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration of seltorexant and its metabolites.
Apparent Terminal Elimination Half-life (t1/2) of Seltorexant and its Metabolites
时间窗: Predose, up to 48 hours post dose (Day 3)
Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve of seltorexant and its metabolites.
次要结局
- Number of Participants with Clinically Significant Changes in Vital Signs(Up to 11 Weeks)
- Number of Participants with Adverse Events (AEs) including AEs of Special Interest (AESI) as a Measure of Safety and Tolerability(Up to 11 Weeks)
- Number of Participants with Laboratory Abnormalities(Up to 11 Weeks)
- Number of Participants with Abnormalities in Electrocardiogram (ECG)(Up to 11 Weeks)
- Number of Participants with Clinically Significant Changes in Physical Examination(Up to 11 Weeks)