ACTRN12623001201662已完成1 期
A Phase 1, Single Center, Open-Label Study to Evaluate the Pharmacokinetics, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Ascending Doses of Dihydroergotamine Mesylate (Zephyr) Inhalation Powder, and Dihydroergotamine Mesylate Intravenous, in Healthy Adult Subjects.
Syneos Health New Zealand Ltd0 个研究点目标入组 28 人开始时间: 2023年11月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Male or female, greater than or equal to 18 and less than or equal to 65 years of age, with BMI >18.5 and <32.0 kg/m2 at screening.
- •2. Healthy as defined by:
- •a. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- •b. the absence of clinically significant history of neurological, endocrine, cardiovascular,
- •pulmonary, hematological (e.g., thrombocytopenia, neutropenia, bleeding disorders),
- •immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- •3. Female subjects of non-childbearing potential must be at screening:
- •a. Post-menopausal defined as aged more than 50 years and amenorrhea for at least 12 months prior to dosing following cessation of all exogenous hormonal treatments.
- •b. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and having luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the
- •post-menopausal range for the institution.
- •c. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
- •4. Female subjects of childbearing potential must be willing to use an acceptable contraceptive method throughout the study. If local regulations deviate from the listed contraception methods and require more extensive measures to prevent pregnancy, local regulations apply and will be described in the Informed Consent Form (ICF). Use of hormone replacement therapy and oral, implantable, transdermal, injectable, or intrauterine hormonal contraceptives is not allowed.
- •5. Female subjects of childbearing potential must not donate ova during the study and for at least 30 days after the last dose of study drug.
- •6. Male subjects who are not vasectomized for at least 3 months prior to dosing, and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first dose and for 90 days after the last dose.
- •7. Male subjects (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose.
- •8. Male subjects must be willing not to donate sperm from the first dose and for 90 days after the last dose.
- •9. Current non-smoker: no use of tobacco or nicotine products, including any smoking cessation nicotine-containing products (i.e., nicotine replacement therapy [patch, spray, inhaler, gum, lozenge, bupropion SR, clonidine and nortriptyline], e-cigarettes, etc.) for at least 3 months prior to screening and no prior heavy smokers will be allowed (heavy smoking defined as the equivalent of 25 or more cigarettes per day).
- •10. Able to understand the study procedures and provide signed informed consent to participate in the study.
排除标准
- •1. Positive pregnancy test or lactating female subjects at screening or prior to dosing.
- •2. Significant history or clinical manifestation of any metabolic, allergic, dermatological,
- •immunological, renal, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal,
- •neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
- •3. History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study at screening. This includes subjects with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or subjects who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal’s variant angina.
- •4. Subject with abnormal lung function defined by spirometry testing such: FEV1 < 80% of
- •predicted normal value OR FEV1/FVC ratio < 0.70 at screening.
- •5. History or current diagnosis of COPD, asthma, including childhood asthma, or bronchospasm at screening.
- •6. History of COVID-19 with unresolved respiratory symptoms and/or unresolved respiratory
- •findings, or any previous hospitalization due to COVID-19.
- •7. Presence of orthodontic braces or orthodontic retention wires, dentures, tongue piercing or any physical findings in the mouth or tongue that would be likely to interfere with completion of the dosing procedure in the opinion of the investigator.
- •8. Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot derived products, or to any excipient in the formulation at screening.
- •9. Blood pressure (BP) measured in a rested and relaxed condition, where systolic BP greater than or equal to 130 mmHg or diastolic BP greater than or equal to 80 mmHg at screening.
- •10. Any of the following cardiac criteria at screening:
- •a. Mean resting QT interval corrected by QTcF > 470 msec (females) or > 450 msec (males)
- •obtained from 3 ECGs.
- •b. Any clinically relevant abnormality in rhythm, conduction or morphology of resting ECG
- •(e.g., complete left bundle branch block, third degree heart block, second degree heart
- •block, PR interval >250 msec).
- •c. Clinically relevant factor which in the opinion of the investigator may increase the risk of
- •QTc prolongation or risk of arrhythmic events (e.g., heart failure, uncorrected hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval).
- •11. History or presence of drug abuse within the 1 year prior to the first study drug administration or a positive result on the urine drug test at the Screening Visit.
- •12. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within
- •6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 375 mL of beer 3.5%, or 100 mL of wine 13.5%, or 30 mL of distilled alcohol
- •13. Positive serology test results for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HbsAg) and/or human immunodeficiency virus (HIV) at screening. Subjects whose results are compatible with prior immunization for HbsAg or natural immunity may be included at the discretion of the investigator.
- •14. Subjects with significant risk factors for coronary artery disease, or history of hypertension, diabetes, kn
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