A Phase 1, Open-label, Three-Part, Fixed-Sequence Trial in Healthy Adult Participants to Evaluate the Effects of Itraconazole and Carbamazepine on the Single-Dose Pharmacokinetics of Emraclidine, and the Effect of Emraclidine on the Single-Dose Pharmacokinetics of Metformin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Part C: AUC0-t of Metformin
研究概览
简要总结
The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of emraclidine on the PK of metformin in Part C in healthy adult participants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part A: Emraclidine Followed by Itraconazole + Emraclidine
Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2.
干预措施: Emraclidine (Drug)
Part A: Emraclidine Followed by Itraconazole + Emraclidine
Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2.
干预措施: Itraconazole (Drug)
Part B: Emraclidine Followed by Carbamazepine + Emraclidine
Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2.
干预措施: Emraclidine (Drug)
Part B: Emraclidine Followed by Carbamazepine + Emraclidine
Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2.
干预措施: Carbamazepine (Drug)
Part C: Metformin Followed by Emraclidine + Metformin
Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2.
干预措施: Emraclidine (Drug)
Part C: Metformin Followed by Emraclidine + Metformin
Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2.
干预措施: Metformin (Drug)
结局指标
主要结局
Part C: AUC0-t of Metformin
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: Cmax of Emraclidine and its Metabolite CV-0000364
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: Cmax of Metformin
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: AUCinf of Emraclidine and its Metabolite CV-0000364
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: AUCinf of Metformin
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part B: AUC0-t of Emraclidine and its Metabolite CV-0000364
时间窗: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
次要结局
- Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values(Up to end of treatment in each part of the study (up to an average of 15 days))
- Number of Participants With Clinically Significant Changes in Vital Sign Measurements(Up to end of treatment in each part of the study (up to an average of 15 days))
- Number of Participants With Clinically Significant Changes in Laboratory Assessments(Up to end of treatment in each part of the study (up to an average of 15 days))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) Based on Severity(From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study)
- Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results(Up to end of treatment in each part of the study (up to an average of 15 days))
- Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score(Up to end of treatment in each part of the study (up to an average of 15 days))