A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AGN-241751 After Oral Administration in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 主要终点
- Treatment emergent adverse events
研究概览
简要总结
To evaluate the safety and tolerability of single ascending doses of zelquistinel in normal human volunteers
详细描述
Single ascending dose (SAD), double-blind placebo-controlled study in normal human volunteers.
Secondary objectives:
To evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of zelquistinel following increasing single doses of zelquistinel.
Zelquistinel or Placebo: Dose/Mode of Administration: Single dose; oral
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple blind
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agree to effective method of birth control
- •If female, negative pregnancy test at screening and Day -1
- •Nonsmoking at least 2 years
- •BMI 18-30
- •Supine pulse rate 30-100
排除标准
- •Known hypersensitivity to NMDA receptor drugs
- •clinically significant disease in any body system
- •QTcF > 430 ms in males, >450 ms in females
- •positive test for hepatitis B or C
- •abnormal liver function tests on Day -1
- •History of alcohol or other substance abuse during the previous 5 years
- •Positive drug screen at screening or Day -1
- •Taken any medication within the past 14 days
研究组 & 干预措施
Placebo
Placebo tablet, PO, Single Dose with 28 day follow up
干预措施: Placebo (Drug)
3 mg zelquistinel
zelquistinel, 3 mg tablet, PO, Single Dose with 28 day follow up
干预措施: zelquistinel (Drug)
100 microgram zelquistinel
zelquistinel, 100 microgram tablet, PO, Single Dose with 28 day follow up
干预措施: zelquistinel (Drug)
1 mg zelquistinel
zelquistinel, 1 mg tablet, PO, Single Dose with 28 day follow up
干预措施: zelquistinel (Drug)
10 mg zelquistinel
zelquistinel, 10 mg tablet, PO, Single Dose with 28 day follow up
干预措施: zelquistinel (Drug)
25 mg zelquistinel
zelquistinel, 25 mg tablet, PO, Single Dose with 28 day follow up
干预措施: zelquistinel (Drug)
50 mg zelquistinel
zelquistinel, 50 mg tablet, PO, Single Dose with 28 day follow up
干预措施: zelquistinel (Drug)
100 mg zelquistinel
zelquistinel, 100 mg tablet, PO, Single Dose with 28 day follow up
干预措施: zelquistinel (Drug)
1 mg zelquistinel with CSF collection
zelquistinel, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection
干预措施: zelquistinel (Drug)
10 mg zelquistinel with CSF collection
zelquistinel, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection
干预措施: zelquistinel (Drug)
结局指标
主要结局
Treatment emergent adverse events
时间窗: 28 days
through study completion
次要结局
- Pharmacokinetics, area under the curve for plasma concentration(72 hours)
- Pharmacokinetics, maximum plasma concentration(24 hours)
- Pharmacokinetics, time to maximum plasma concentration(24 hours)
研究者
Ronald M Burch MD PhD
Chief Medical Officer
Gate Neurosciences, Inc