A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects with Narcolepsy and Idiopathic Hypersomnia – (CRYSTAL-1)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 27
- 主要终点
- Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.
研究概览
简要总结
To evaluate the safety and tolerability of ORX750
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •BMI ≥17 and ≤37 kg/m2
- •Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria
- •Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia
- •Is willing and able to adhere to additional protocol requirements
排除标准
- •A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).
- •Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
结局指标
主要结局
Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.
Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.
次要结局
- PK-Day 1: Cmax, tmax, and AUC0-last; Days 14 and 28: Cmax,ss, tmax, and AUCτ, and other PK parameters as appropriate.
- PD-mean sleep latency (average of the first 4 trials) in the MWT for ORX750 versus placebo and subjective daytime sleepiness using the ESS, including change from baseline to specified postdose time points.
研究者
Senior Vice President, Clinical Development
Scientific
Centessa Pharmaceuticals UK Limited