ACTRN12620000234910已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetic Response of Zolmitriptan Following Multiple Ascending Doses in Adult Healthy Volunteer Subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Healthy adult male and female subjects ages 18 to 45 years (inclusive).
- •2.Negative screen for drugs of abuse.
- •3.Body mass index (BMI) 18 through 32 kg/m2, inclusive.
- •4.Male subjects and female subjects of childbearing potential that are sexually active must practice effective contraception from screening of the study through to 30 days after their last dose of study drug. Effective contraception is the use of two contraception methods, defined as condom use (male and/or female type), hormonal contraception (women) or IUD. This does not apply to participants who are surgically sterilized by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, or participants who practice sexual abstinence while a research subject in this study, or participants in same-sex relationships.
- •5.Ability to participate, willingness to give written informed consent, and willingness to comply with the study restrictions.
排除标准
- •1.1.Have taken, with 4 weeks of Screening or Intake, any of the following:
- •Selective Serotonin Reuptake Inhibitors (SSRIs)
- •Serotonin-Norepinephrine Reuptake Inhibitor (SNRIs).
- •Any MAO-O inhibitor
- •Another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication (example: dihydroergotamine or methysergide), including St John’s wort
- •Any MAO-A inhibitor
- •2.Are taking cimetidine and are unable to discontinue use of cimetidine from Screening until the End of Study follow-up.
- •3.Significant current use of tobacco products, as judged by the Investigator.
- •4.Have a diagnosis or clinical history of cardiac, cerebrovascular or peripheral vascular disease, including Prinzmetal’s angina and Wolff-Parkinson-White syndrome
- •5.Screening or Intake systolic blood pressure =180mmHg (confirmed with repeat readings), or a clinical history of uncontrolled or severe hypertension.
- •6.Evidence of clinically significant ECG abnormalities at Screening or Baseline, in the clinical judgement of the Investigator.
- •7.Screening or Intake liver function tests that demonstrate an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3X the upper limit of normal.
- •8.Diagnosed with, or clinical history of epilepsy or structural brain lesions reported at screening.
- •9.Known history of alcohol use disorder or other substance use disorder within 6 months prior to Screening.
- •10.Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening.
- •11.Pregnant or lactating female subjects.
- •12.History of galactose intolerance (i.e. Lapp lactase deficiency or glucose-galactose malabsorption).
- •13.Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
- •14.Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk of safety/tolerability issues and/or would preclude obtaining voluntary consent and/or would confound the interpretation of the primary outcome measures in the study.
- •15.Unwillingness or inability to comply with the study protocol, (including abstaining from all tobacco products during the dosing period), for any other reason.
研究者
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