A Phase 1, Single-center, Two-part, Open-label, Pharmacokinetic Trial to Assess the Potential for Cytochrome P450 3A Mediated Drug-drug Interactions With Orally Administered OPC-167832 Tablets in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Part 2: AUCt of OPC-167832
研究概览
简要总结
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832. The study is conducted in 2 parts: Part 1 assesses the potential effect of the CYP3A inhibitor itraconazole on the metabolism of OPC-167832 and Part 2 assesses the potential effect of the CYP3A inducer carbamazepine on the metabolism of OPC-167832 in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
- •In good health at screening as determined by:
- •Medical history
- •Physical examination
- •Serum/urine chemistry, hematology, and serology tests
- •Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial
排除标准
- •Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participants at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- •History of drug and/or alcohol abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe alcohol/substance use disorder) within 2 years prior to the screening visit.
- •History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen, hepatitis C antibodies, and/or human immunodeficiency virus antibodies.
- •History of any clinically significant drug allergy or known or suspected hypersensitivity, to any component of the IMP including structurally related drugs (eg, tricyclic antidepressants), hereditary fructose intolerance (Part 1 only), or any of the excipients.
- •A positive urine alcohol test and/or urine drug screen for substances of abuse at the screening visit or upon check-in to the trial site.
- •Participants having taken an investigational drug within 30 days prior to the screening visit.
- •Any history of clinically significant hemorrhagic tendencies.
- •Having received a vaccine within 14 days prior to dosing
- •Any participant who, in the opinion of the investigator, should not participate in the trial.
- •Female participants who are breast-feeding or who have a positive pregnancy test result prior to receiving IMP.
- •Participants without a permanent physical residence.
- •History of suicide ideation or severe depression that, in the opinion of the investigator, would exclude the participant from participating in this trial (applicable to Part 2 only).
- •Note: Other protocol-specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part 1: OPC-167832 and Itraconazole
Participants receive single OPC-167832 dose, orally on Days 1 and 15, and itraconazole, orally, twice daily (BID), on Day 8 followed by itraconazole, once daily (QD) from Day 9 to Day 25 of Part 1.
干预措施: OPC-167832 (Drug)
Part 2: OPC-167832 and Carbamazepine
Participants receive single OPC-167832 dose, orally on Days 1 and 25, and carbamazepine Dose 1, orally, BID from Day 8 to Day 10, followed by Dose 2, BID from Day 11 to Day 13, and Dose 3, BID from Day 14 to Day 31 of Part 2.
干预措施: OPC-167832 (Drug)
Part 2: OPC-167832 and Carbamazepine
Participants receive single OPC-167832 dose, orally on Days 1 and 25, and carbamazepine Dose 1, orally, BID from Day 8 to Day 10, followed by Dose 2, BID from Day 11 to Day 13, and Dose 3, BID from Day 14 to Day 31 of Part 2.
干预措施: Carbamazepine (Drug)
Part 1: OPC-167832 and Itraconazole
Participants receive single OPC-167832 dose, orally on Days 1 and 15, and itraconazole, orally, twice daily (BID), on Day 8 followed by itraconazole, once daily (QD) from Day 9 to Day 25 of Part 1.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Part 2: AUCt of OPC-167832
时间窗: Up to Day 32
Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832
时间窗: Up to Day 26
Part 2: Cmax of OPC-167832
时间窗: Up to Day 32
Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at time t (AUCt) of OPC-167832
时间窗: Up to Day 26
Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832
时间窗: Up to Day 26
Part 2: AUCinfinity of OPC-167832
时间窗: Up to Day 32
次要结局
- Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Vital Signs(Part 1: Up to 8 weeks; Part 2: Up to 9 weeks)
- Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters(Part 1: Up to 8 weeks; Part 2: Up to 9 weeks)
- Part 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)(Part 2: Up to 9 weeks)
- Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Part 1: Up to 8 weeks; Part 2: Up to 9 weeks)
- Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters(Part 1: Up to 8 weeks; Part 2: Up to 9 weeks)
- Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Physical Examinations(Part 1: Up to 8 weeks; Part 2: Up to 9 weeks)