A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Part A
研究概览
简要总结
Characterize the safety, tolerability and pharmacokinetics of ORX489 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 60 Years（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 D: Participants must be at least 18 years of age and no more than 60 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: ORX489 and Placebo
干预措施: ORX489 Tablets (Drug)
Part A
SAD Study in Healthy Adults: ORX489 and Placebo
干预措施: Placebo Tablets (Other)
Part B
Food-effect Evaluation in Healthy Adults: ORX489
干预措施: ORX489 Tablets (Drug)
Part C
MAD Study in Healthy Adults: ORX489 and Placebo
干预措施: ORX489 Tablets (Drug)
Part C
MAD Study in Healthy Adults: ORX489 and Placebo
干预措施: Placebo Tablets (Other)
Part D
SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo
干预措施: ORX489 Tablets (Drug)
Part D
SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo
干预措施: Placebo Tablets (Other)
结局指标
主要结局
Part A
时间窗: From enrollment to the Follow-Up Visit 7 days post-discharge
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in healthy adult participants.
Part B
时间窗: From enrollment to the Follow-Up Visit 7 days post-discharge]
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in the fasted and fed states
Part C
时间窗: From enrollment to the Follow-Up Visit 7 days post-discharge]
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral multiple ascending doses of ORX489 in healthy adult participants
Part D:
时间窗: From enrollment to the Follow-Up Visit 7 days post-discharge
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single oral doses of ORX489 in sleep-deprived healthy adult participants
次要结局
- Cmax(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- Tmax(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- AUClast(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- T 1/2 (terminal elimination half-life)(Pre-dose and multiple post-dose timepoints, up to 48 hours)
- Mean sleep latency in the Maintenance of Wakefulness Test (MWT)(Part D: Day 1-2)
- Karolinska Sleepiness Scale score(Part D: Day 1-2)