NCT06363630招募中1 期
A Phase 1, Open-label, 2-part, 2-period, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of Golcadomide (BMS-986369) in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Celgene
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Healthy male and female non smoking participants, of any race, as determined by the investigator to have no clinically significant deviation from normal, in medical history and physical examination which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data, in 12-lead ECG measurements, vital signs, and clinical laboratory determinations, at screening and at check-in.
- •Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants.
- •Participant is afebrile (febrile is defined as ≥ 38°C or ≥ 100.4°F), with systolic blood pressure ≥ 90 and ≤ 140 mmHg, diastolic blood pressure ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 90 beats per minute at screening, confirmed by repeat, as per clinical site's standard.
- •Must have a normal or clinically acceptable 12-lead ECG at screening: Participants must have a corrected QT interval using QTcF value ≤ 450 msec.
- •Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -
- •Must have adequate laboratory test results for renal and hepatic function as assessed by the PI (Principal Investigator). Laboratory testing may be repeated to find all possible well-qualified participants.
排除标准
- •Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study.
- •History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases.
- •Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME). Appendectomy and cholecystectomy are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 1
Experimental
干预措施: Itraconazole (Drug)
Part 1
Experimental
干预措施: Golcadomide (Drug)
Part 2
Experimental
干预措施: Rifampin (Drug)
Part 2
Experimental
干预措施: Golcadomide (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
时间窗: Up to Day 67
Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 67
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to Day 67
次要结局
- Number of participants with clinical laboratory safety test abnormalities(Up to Day 69)
- Number of participants with adverse events (AEs)(Up to Day 69)
- Number of participants with vital sign abnormalities(Up to Day 69)
- Number of participants with physical exam abnormalities(Up to Day 69)
- Number of participants with electrocardiogram abnormalities(Up to Day 69)
- Number of participants with concomitant medications(Up to Day 69)
- Number of participants with concomitant procedures(Up to Day 69)
- Time of maximum observed plasma concentration (Tmax)(Up to Day 67)
- Apparent terminal phase half-life (T-HALF)(Up to Day 67)
- Apparent total body clearance (CLT/F)(Up to Day 67)
- Apparent volume of distribution (Vz/F)(Up to Day 67)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Drug to Drug Interaction Study of KBP-5074 in Healthy SubjectsHealthyDrug Drug InteractionNCT04606537KBP Biosciences24
已完成
1 期
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)HypercholesterolemiaNCT00653913Organon and Co18
招募中
1 期
To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy AdultsDyslipidemiasType 2 DiabetesNCT06578676Hyundai Pharm56
已完成
1 期
Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy SubjectsHealthyNCT01471717Bristol-Myers Squibb32
已完成
1 期
Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult VolunteersHealthyNCT02089399Daewoong Pharmaceutical Co. LTD.32