A Single-center, Open-label, Randomized, Three-way Cross-over Study Evaluating Drug Drug Interaction Between JNJ-70033093 and Atorvastatin in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24hours]) of Atorvastatin in Healthy Participants at Steady State
研究概览
简要总结
The purpose of this study is to evaluate the potential pharmacokinetics (PK) interaction between milvexian and atorvastatin (and its metabolites) in healthy participants at steady state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 on the basis of physical examination, medical history, vital signs, Electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis, performed at screening.
- •Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) of greater than or equal to (>=) 90 milliliter per minute per 1.73 square meters (mL/min/1.73 m^2) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- •Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and are willing to participate in the study
- •If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine (beta-hCG) pregnancy test on Day 1 of each treatment period
- •Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
排除标准
- •Participant is a woman who is pregnant, breastfeeding, or planning to become pregnant during this study or within 34 days after the last study drug administration
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, gastrointestinal disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Clinically significant abnormal values for hematology, coagulation, clinical chemistry (including thyroid-stimulating hormone [TSH] at screening only), or urinalysis at screening or on Day 1 prior to the first dosing, including: Hemoglobin and hematocrit less than (<) lower limit of normal; Platelet count < lower limit of normal; and activated partial thromboplastin time (aPTT) or prothrombin time (PT) greater than (>) 1.2* upper limit of normal (ULN)
- •Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study center on Day 1 prior to first dosing, as deemed appropriate by the investigator
- •Participants with a history of excessive menstrual bleeding
研究组 & 干预措施
Treatment Sequence ABC
Participants will receive milvexian capsule once daily (qd) for 5 days (Treatment A) in Period 1 followed by Atorvastatin tablets qd for 5 days (Treatment B) in Period 2 followed by milvexian capsules qd and atorvastatin tablets qd for 5 days (Treatment C) in Period 3. Each period is separated by a washout period of 7 days.
干预措施: Milvexian (Drug)
Treatment Sequence ABC
Participants will receive milvexian capsule once daily (qd) for 5 days (Treatment A) in Period 1 followed by Atorvastatin tablets qd for 5 days (Treatment B) in Period 2 followed by milvexian capsules qd and atorvastatin tablets qd for 5 days (Treatment C) in Period 3. Each period is separated by a washout period of 7 days.
干预措施: Atorvastatin (Drug)
Treatment Sequence BCA
Participants will receive Treatment B in Period 1 followed by Treatment C in Period 2 and Treatment A in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Milvexian (Drug)
Treatment Sequence BCA
Participants will receive Treatment B in Period 1 followed by Treatment C in Period 2 and Treatment A in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Atorvastatin (Drug)
Treatment Sequence CAB
Participants will receive Treatment C in Period 1 followed by Treatment A in Period 2 and Treatment B in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Milvexian (Drug)
Treatment Sequence CAB
Participants will receive Treatment C in Period 1 followed by Treatment A in Period 2 and Treatment B in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Atorvastatin (Drug)
Treatment Sequence CBA
Participants will receive Treatment C in Period 1 followed by Treatment B in Period 2 and Treatment A in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Milvexian (Drug)
Treatment Sequence CBA
Participants will receive Treatment C in Period 1 followed by Treatment B in Period 2 and Treatment A in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Atorvastatin (Drug)
Treatment Sequence ACB
Participants will receive Treatment A in Period 1 followed by Treatment C in Period 2 and Treatment B in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Milvexian (Drug)
Treatment Sequence ACB
Participants will receive Treatment A in Period 1 followed by Treatment C in Period 2 and Treatment B in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Atorvastatin (Drug)
Treatment Sequence BAC
Participants will receive Treatment B in Period 1 followed by Treatment A in Period 2 and Treatment C in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Milvexian (Drug)
Treatment Sequence BAC
Participants will receive Treatment B in Period 1 followed by Treatment A in Period 2 and Treatment C in Period 3. Each Period is separated by a washout period of 7 days.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24hours]) of Atorvastatin in Healthy Participants at Steady State
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2 and 3
AUC(0-24 hours) is the area under the plasma concentration-time curve from time zero to 24 hours of Atorvastatin at Steady State.
Maximum Observed Plasma Concentration (Cmax) of Milvexian at Steady State
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2, 3
Cmax is the maximum observed plasma concentration of milvexian at Steady State.
Maximum Observed Plasma Concentration (Cmax) of Atorvastatin at Steady State
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2, 3
Cmax is the maximum observed plasma concentration of Atorvastatin at Steady State.
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24hours]) of Milvexian at Steady State
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2 and 3
AUC(0-24 hours) is the area under the plasma concentration-time curve from time zero to 24 hours of milvexian at Steady State.
次要结局
- AUC(0-24 hours) of Milvexian After a Single Dose Administration(Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24 hours after drug administration on Day 1 in Period 1, 2, 3)
- Cmax of Atorvastatin After a Single Dose Administration(Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24, 48, 72 hours after drug administration on Day 1 in Period 1, 2, 3)
- AUC(0-24 hours) of Atorvastatin After a Single Dose Administration(Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24 hours after drug administration on Day 1 in Period 1, 2, 3)
- Number of Participants with Adverse Event as a Measure of Safety and Tolerability(Up to 3.4 months)
- Change From Baseline in Activated Partial Thromboplastin Time (aPTT)(Baseline, Day 2 and Day 6)
- Cmax of Milvexian After a Single Dose Administration(Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24, 48, 72 hours after drug administration on Day 1 in Period 1, 2, 3)