A Two-Part, Open-Label, Randomized, Placebo-Controlled, Crossover Study to Assess the Reversal of the Anticoagulant Effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Subjects - Reversal of the Anticoagulant Effects of Milvexian (JNJ-70033093)

Janssen-Cilag International NV0 个研究点目标入组 46 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Participants must be male or female between 18 and <55 years of age.
•2. Participants must be healthy on the basis of medical history, physical
•examination, vital signs, ECG, and laboratory test results.
•3. If a woman, must have a negative highly sensitive serum (β-human chorionic
•gonadotropin [β-hCG]) pregnancy test at screening and urine (β-hCG) pregnancy
•test on Day -1 of each study period (Part 1) or on Day -1 of Period 1 (Part 2).
•4. Body mass index (weight [kg]/height^2 [m]^2) >=18.0 and <29.9 kg/m^2 body
•weight not less than 50 kg and not more than 100 kg.
•5. After being supine for 5 minutes, systolic blood pressure between 90 and 140
•mmHg, inclusive; and no higher than 90 mmHg diastolic, inclusive.
•For a complete overview see the protocol

•1. If a woman, pregnant, breast-feeding or planning to become pregnant during
•2. History or family history of any known illness that, in the opinion of the
•investigator, might confound the results of the study or pose an additional
•risk in administering study intervention to the subject or that could prevent,
•limit or confound the protocol specified assessments.
•3. Participants with current hepatitis B infection, or hepatitis C infection,
•or human immunodeficiency virus type1 (HIV-1) or HIV-2 infection at study
•4. History of any significant drug allergy (such as anaphylaxis or
•hepatotoxicity) and known allergy to the study intervention or any of the
•excipients of the formulations. History of allergy to or unwillingness to
•consume any component of high-fat breakfast menu to be provided in this study.
•5. Any of the following laboratory results outside of the ranges specified
•below at screening or on Day -1 of Period 1, confirmed by repeat: a. Hemoglobin
•or hematocrit < lower limit of normal
•b. Platelet count < lower limit of normal c. aPTT, or PT > ULN d. Low-density
•lipoprotein (LDL), High-density lipoprotein (HDL), apolipoprotein B, or
•lipoprotein a, outside the normal reference ranges
•(at the screening visit only)
•For a complete overview see the protocol

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