EUCTR2021-004009-37-NL进行中（未招募）1 期
A Phase 1/2 study of the dose-response in pharmacodynamics and safety of prothrombin complex concentrate Cofact in healthy subjects under vitamin K antagonist anticoagulation
Prothya Biosolutions BV0 个研究点目标入组 120 人开始时间: 2021年9月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Sex : Male or female of nonchildbearing potential.
- •2. Age : 18 to 55 years, inclusive, at screening.
- •3. Body mass index (BMI) :18.0 to 30.0 kg/m2, inclusive, at screening. Body weight is not less than 50 kg and not more than 100 kg.
- •4. Status: Healthy subjects.
- •5. Female subjects will be included if they are of nonchildbearing potential. Female subjects should have a documented history of tubal ligation more than 6 months prior to the onset of the study, or with a documented hysterectomy. Postmenopausal women will be included in the study if the postmenopausal status is confirmed with a history of 12 months uninterrupted spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels >40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •6. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the EOS visit. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
- •7. Subjects should not be taking any prescribed medication for at least 14 days prior to first admission to the clinical research center.
- •8. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John’s wort) must have been stopped at least 14 days prior to first admission to the clinical research center.
- •9. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to each admission into the clinical research center.
- •10. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to the first admission to the clinical research center on Day -11 up to admission to the clinical research center on Day 1.
- •11. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.
- •12. Computerized 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator. The ECG may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate.
- •13. All values for clinical laboratory tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator. Clinical laboratory tests may be repeated if they are just out of range, or there is a reason to believe the initial results are inaccurate (eg, clumped platelets).
- •14. Willing and able to sign the ICF.
- •15. The INR is 2.0 to 3.0 (inclusive) at least in one of the two INR measurements taken on Day 1 after acenocoumarol has been administered for 10 days. The INR is measured twice predose on Day 1, one via the blood draw and the other via the device.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
排除标准
- •1. Employee of PRA or the Sponsor.
- •2. History of relevant drug and/or food allergies.
- •3. Any of the following laboratory results outside of the ranges, at screening: lupus anticoagulants (LA screen) and/or anti-beta2-glycoprotein I, low levels of protein C (activity), low levels of protein S (activity), or low levels of antithrombin.
- •4. Abnormal aPTT or PT levels, or Fe or ferritin levels.
- •5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and total bilirubin are not more than about 1.2 times the upper limit of normal at screening (per the Investigator’s discretion).
- •6. Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
- •7. Prior history of thromboembolic complications including those in first degree relatives.
- •8. Glomerular filtration rate (GFR) is lower than estimated GFR 62 mL/min/1.73 m2 using the Modification of Diet in Renal Disease Study equation.
- •9. Anaphylactic or systemic reactions to human plasma, plasma products, or blood products.
- •10. History of hypersensitivity to active or inactive excipients of acenocoumarol or drugs with a similar chemical structure or class.
- •11. Gastrointestinal disease that may impair acenocoumarol absorption..
- •12. On medication that may affect acenocoumarol activity, such as aspirin, acetaminophen (with prolonged use [longer than 4 days] and in high doses (4 g per day), antibiotics, antifungals, or allergy medication.
- •13. Any regular medication involving hepatic metabolism, increasing risk for thrombosis, or otherwise affecting hemostasis.
- •14. Significant psychiatric illness that could interfere with the ability to comprehend and comply with study procedures and ability to tolerate treatment as outlined in the protocol.
- •15. Participation in another clinical study <30 days prior to study entry.
- •16. Any clinically significant history of or current clinically significant other disease or disorder – gastrointestinal (including gastrointestinal bleeding of any origin), cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic - as judged by the Investigator.
- •17. Any clinically significant abnormality following the Investigator’s review of physical examination findings, and clinical laboratory tests obtained at screening.
- •18. An abnormal pulse rate and/or blood pressure measurements at the screening visit: pulse rate <40 or >100 beats per minute (bpm); systolic blood pressure <90 or >140 mmHg; diastolic blood pressure <50 or >90 mmHg (to be confirmed by a second measurement, after subject has been resting in supine position for 5 min). If initial results do not meet these criteria, blood pressure and/or pulse may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate (eg, white coat hypertension).
- •19. Whole blood or plasma donation of more than 100 mL within 30 days prior to administration of study medication or intended donation during the study.
- •20. Judgment by the Investigator that the subject should not participate in the study because the subject is unlikely to comply with all study procedures and treatment.
- •21. Unsuitable veins for infusion or blood sampling.
- •22. Subjects who have not reached an INR of 2.0 to 3.0 (inclusive) on at least 1 of the measurements on Day -1Day 1, after receiving
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