A First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Oral Dose Study Of SUVN-I6107 To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of food on SUVN-I6107 pharmacokinetics and 4) to evaluate the pharmacodynamic (PD) effects of single and multiple ascending oral doses of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potential (ERP) assessments.
详细描述
This research study is a randomized, single-center, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD), first-in-human study in healthy participants.
This study consist of 2 segments: Segment 1 will be the SAD portion and Segment 2 will be the MAD portion.
Segment 1 will include up to 5 sequential cohorts. Up to 40 healthy male or female subjects, ages 18 - 45 years (inclusive) old at screening will be enrolled.
Segment 2 will include up to 3 sequential cohorts. The dosing will be administered for 14 consecutive days. Up to 24 healthy male or female subjects, ages 50 to 80 years (inclusive) old at screening will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Body mass index (BMI): 18.0 to 30.0 kg/m2 for Segment 1 and 18.0 to 32.0 kg/m2 for Segment 2, inclusive, at screening and weight at least 50 kg and no more than 100 kg.
- •Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to each admission to the clinical facility until study discharge.
- •All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator, at screening and at admission.
排除标准
- •Females who are pregnant, lactating, planning to become pregnant, or planning to donate ova/oocytes during this study or within 30 days after last administration of study drug.
- •Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of admission to the clinical site.
研究组 & 干预措施
Single Ascending Dose
single ascending doses administered orally
干预措施: SUVN-I6107 (Drug)
Single Ascending Dose
single ascending doses administered orally
干预措施: Placebo (Drug)
Multiple Ascending Dose
multiple ascending doses administered orally for 14 days.
干预措施: SUVN-I6107 (Drug)
Multiple Ascending Dose
multiple ascending doses administered orally for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2)
Number of participants with adverse events (AE), discontinuations due to AE or serious adverse event \[SAE\], and withdrawals from the study due to AE.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
时间窗: From Baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Descriptive statistics of QTcF for observed values and changes from baseline will be summarized at each scheduled time point.
Number of Participants With Clinically Significant Changes in Blood Pressure
时间窗: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Pulse Rate
时间窗: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Body Temperature
时间窗: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Respiration Rate
时间窗: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
时间窗: From baseline to Day 24 (Segment 2)
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
次要结局
- Area under the concentration-time curve (AUC)(Day 1 and Day 14)
- Maximum observed concentration (Cmax)(Day 1 and Day 14)
- Time to reach maximum concentration (Tmax)(Day 1 and Day 14)
- Terminal half-life (t½)(Day 1 and Day 14)