A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 3
- 主要终点
- Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects
研究概览
简要总结
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind (investigator- and subject-blinded)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females as determined by assessments at the Screening Visit.
- •For Parts A, B, C, and E:
- •a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening
- •For Part D:
- •a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening
排除标准
- •Presence of significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations.
- •History of seizure disorder, any other condition that increases the risk of seizure
- •Has a clinically significant sleep disorder, including insomnia or sleep apnea.
研究组 & 干预措施
Part A: SAD Study in Healthy Adults
干预措施: ORX142 Tablets (Drug)
Part A: SAD Study in Healthy Adults
干预措施: Placebo Tablets (Other)
Part B: Food-effect Evaluation in Healthy Adults
干预措施: ORX142 Tablets (Drug)
Part C: MAD Study in Healthy Adults
干预措施: ORX142 Tablets (Drug)
Part C: MAD Study in Healthy Adults
干预措施: Placebo Tablets (Other)
Part D: Evaluation of a Single Dose in Healthy Older Adults
干预措施: ORX142 Tablets (Drug)
Part D: Evaluation of a Single Dose in Healthy Older Adults
干预措施: Placebo Tablets (Other)
Part E: PoC Study in Acutely Sleep-deprived Healthy Adults
干预措施: ORX142 Tablets (Drug)
Part E: PoC Study in Acutely Sleep-deprived Healthy Adults
干预措施: Placebo Tablets (Other)
结局指标
主要结局
Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects
时间窗: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states
时间窗: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects
时间窗: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects
时间窗: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects
时间窗: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
次要结局
- Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo.(Part E: Day 2)
- AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 in the fast and fed state(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state.(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- Karolinska Sleepiness Scale score for ORX142 versus placebo(Part E: Day 1-2)