EUCTR2015-003923-74-GB进行中（未招募）1 期
A randomized, double-blind, 4 week, placebo-controlled, dose-ranging, parallel-group study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BCX7353 as a preventative treatment to reduce the frequency of attacks in subjects with hereditary angioedema
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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. Able to provide written, informed consent
- •2. Males and non-pregnant, non-lactating females age 18 to 70 years
- •3. A clinical diagnosis of hereditary angioedema Type 1 or Type 2 as
- •documented at any time in the medical records or at the screening visit
- •a. A low C1 INH antigenic level OR
- •b. A low C1 INH functional level
- •4. All subjects must have:
- •a. An HAE attack rate of <> prior to the screening visit as documented in acceptable source records.
- •b. <> with zero HAE attacks in the <> prior to the screening visit as documented in acceptable source records.
- •5. Access to and ability to use 1 or more acute medications approved by the relevant competent authority for the treatment of acute attacks of HAE
- •6. Female participants must meet at least 1 of the following requirements:
- •a. Be a woman of childbearing potential who agrees to use at least 1 highly effective contraceptive method during the study and for a
- •duration of 30 days after last dose of study drug. One or more of the following methods are acceptable:
- •§ surgical sterilization (ie, bilateral tubal occlusion or vasectomy of male partner)
- •§ placement of an intrauterine device (IUD) or intrauterine system (IUS) (implanted any time prior to or during screening)
- •§ progesterone-only (implantable or injectable only) hormonal contraception associated with inhibition of ovulation excluding
- •desogestrel initiated at least 60 days prior to the screening visit
- •Female subjects who report being postmenopausal for = 2 years and have a screening follicle stimulating hormone (FSH) = 40 mIU/mL must
- •agree to use at least 1 highly effective contraceptive method and (as proposed above) during study and for 30 days after dose of study drug.
- •b. Be a woman of nonchildbearing potential.
- •c. Be a woman declaring herself as either sexually abstinent or exclusively having female sexual partners.
- •7. Male subjects must comply with the following requirements for a duration of 90 days after last dose of study drug:
- •a. Subjects with female partners of childbearing potential must agree to utilize at least 1 highly effective contraceptive method. At least 1 or
- •more of the following methods are acceptable:
- •§ surgical sterilization (ie, vasectomy or bilateral occlusion of a female partner)
- •§ placement of an IUD or IUS
- •§ any form of hormonal contraception that is associated with inhibition of ovulation (oral, implantable, injectable, intravaginal, or transdermal)
- •b. Male subjects who declare themselves as sexually abstinent are acceptable for the purposes of this study.
- •c. Must abstain from sperm donation for a period of 90 days after last dose of study drug.
- •8. Any concomitant medication recorded at the screening visit and not stated as exclusionary must be anticipated to be continued through the
- •entire study and be of a stable dose and regimen for the duration of the entire study.
- •9. In the opinion of the Investigator, the subject is expected to adequately comply with all required study procedures for the duration of
- •the study. The subject must demonstrate adequate compliance with all study procedures required from the screening visit through
- •randomization, including e-diary recording of HAE attacks beginning at the screening visit.
- •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 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator or Sponsor, would
- •interfere with the subject's ability to participate in the study or increase the risk of participation for that subject.
- •2. Clinically significant abnormal ECG at the screening visit. This includes, but is not limited to, a QTcF > 470 msec, a PR > 220 msec, or
- •ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping.
- •3. Any clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular
- •hypertrophy, cardiomyopathy, or any other cardiovascular abnormality.
- •4. Family history of sudden death from causes other than HAE.
- •5. History of or current implanted defibrillator or pacemaker.
- •6. Any abnormal laboratory or urinalysis parameter at screening that, in the opinion of the Investigator, is clinically significant and relevant for
- •this study. A calculated creatinine clearance of = 60 mL/min or AST or ALT value = 2 times the upper limit of the normal reference range.
- •7. Concurrent use of angiotensin converting enzyme inhibitors from the screening visit or expected use at any time through the end of the study.
- •8. Use of a medication that is clinically known to induce or inhibit drug transporters at the screening visit or anticipated use through the followup
- •visit, including no use for a minimum of 7 days prior to Day 1.
- •9. Use of a medication that is clinically known or suspected to prolong the QT interval at the screening visit or anticipated use through the
- •follow-up visit, including no use for a minimum of 7 days prior to Day 1.
- •10. Use of a medication that primarily relies upon CYP2C9, CYP2C19, CYP2D6 and CYP3A4 for metabolism (eg, any P450 substrates listed on
- •the Indiana University Clinical Pharmacology website) at the screening visit or anticipated use through the follow-up visit, including no use for a
- •minimum of 7 days prior to Day 1.
- •11. Initiation of a progesterone contraceptive within 60 days of the screening visit (except subjects who switch from desogestrel).
- •12. Use of desogestrel (a progesterone contraceptive) is excluded; however, subjects who take a desogestrel-based contraceptive may
- •switch to an injectable or implantable progesterone-only contraceptive at any time prior to randomization.
- •13. Use of an estrogen-containing hormonal contraceptive within 60 days of the screening visit.
- •14. Use within the 7 days prior to the screening visit or expected use at any time through the end of the study of C1 INH, androgens or
- •tranexamic acid for prophylaxis of HAE attacks. Use of a C1 INH therapy for treatment of acute attacks is not excluded at any time.
- •15. Current participation in any other investigational drug study or received another investigational drug within 30 days of the screening
- •16. History of alcohol or drug abuse within the previous year prior to the screening visit, or current evidence of substance dependence or abuse
- •(self-reported alcoholic intake > 3 drinks/day).
- •17. Positive serology for human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •18. Pregnant, planning to become pregnant within 30 days of the study, or nursing.
- •19. Positive drugs of abuse screen (unless as used as medical treatment, eg, with a prescription).
- •20. History of severe hypersensitivity to any medicina
研究者
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