NCT05359055已完成1 期
An Open-label, Fixed Sequence Study to Evaluate the Effects of Multi-dose of Itraconazole or Rifampin on the Pharmacokinetic Profiles of Single Dose of SPH3127 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum serum concentration (Cmax) of SPH3127
研究概览
简要总结
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent;
- •Chinese Male ≥18 and ≤45 years；
- •BMI≥18.5 and ≤26.0 kg/m2 and a weight ≥50.0 kg;
- •Normal or no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the vital signs, physical examination, clinical laboratory tests, and 12-lead ECG.
- •Subjects agreed to have no family planning during the study period and within 6 months after the last study drug administration, voluntarily take effective contraceptive measures and have no sperm donation plan. Non-drug contraceptive measures will be used voluntarily during the trial.
- •Subjects can communicate well with investigators, understand and comply with the requirements of this trial.
排除标准
- •Patients with diseases that need to be excluded, not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone, and other systems;
- •History of allergic diseases;
- •History of dysphagia or any gastrointestinal illness that affects drug absorption;
- •Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug;
- •People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before screening;
- •Prescribed medications, over-the-counter medications, dietary supplements, or Chinese herbal medicines were taken within 14 days prior to initial administration of the study drug;
- •Unwilling to avoid vigorous exercise from 48 hours before the first administration of the study drug to the end of the study;
- •Used of any drug that inhibits or induces hepatic metabolism of the drug in the 28 days prior to taking the study drug.
- •Those who have special dietary requirements and cannot follow a uniform diet;
- •Assessed by the investigators as unsuitable for participating in the study.
研究组 & 干预措施
Cohort 1
Experimental
SPH3127 tablet, Itraconazole
干预措施: SPH3127 tablet (Drug)
Cohort 1
Experimental
SPH3127 tablet, Itraconazole
干预措施: Itraconazole (Drug)
Cohort 2
Experimental
SPH3127 tablet, Rifampin
干预措施: SPH3127 tablet (Drug)
Cohort 2
Experimental
SPH3127 tablet, Rifampin
干预措施: Rifampin (Drug)
结局指标
主要结局
Maximum serum concentration (Cmax) of SPH3127
时间窗: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127
时间窗: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127
时间窗: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
次要结局
- Half-life (t1/2) of SPH3127(Up to 14 days)
- Apparent oral clearance (CL/F) of SPH3127(Up to 14 days)
- Apparent oral volume of distribution (Vz/F) of SPH3127(Up to 14 days)
- Number of subjects with adverse event.(Up to 42 days)
- Time of maximum serum concentration (Tmax) SPH3127(Up to 14 days)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple SubstratesDrug-InteractionsNCT04764851Emalex Biosciences Inc.30
已完成
1 期
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and TransportDrug InteractionNCT05334108Emalex Biosciences Inc.56
已完成
1 期
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active MetaboliteDrug InteractionNCT04902105Emalex Biosciences Inc.38
招募中
1 期
Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult SubjectsPharmacokineticsNCT06379958Modern Biosciences Ltd48
已完成
1 期
A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult SubjectsHealthyNCT05928988Jiangsu HengRui Medicine Co., Ltd.17