ACTRN12621000461897已完成1 期
A Phase 1 Open Label Crossover Study to assess safety and bioavailability of ML-004-ER under Fasted and Fed Conditions in Adult Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
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 45 Years（—）
- 性别
- All
入选标准
- •1. Healthy adult male and female participants ages 18 to 45 years (inclusive).
- •2. Negative for drugs of abuse at Screening.
- •3. Body mass index (BMI) 21 to 32 kg/m2, inclusive.
- •4. Contraception:
- •a. If female, is either:
- •i. Not of childbearing potential, defined as postmenopausal (>/= 12 continuous months of amenorrhea with no other cause than menopause) or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, participants who practice sexual abstinence as part of their preferred and usual lifestyle, or participants in same-sex relationships.
- •ii. Of childbearing potential and participates in any activity associated with risk of pregnancy and is practicing at least 1 highly effective method of birth control (e.g., intrauterine device, oral or parenteral contraceptives, a vasectomized partner, abstinence from sexual intercourse). The Principal Investigator (PI) will discuss with the participant the option of practicing more than 1 of the above methods for the duration of the study through to 90 days post last dose.
- •b. If male and not surgically sterile, and partner is of childbearing potential, participant agrees to use male condom with spermicide (double-barrier method) for the duration of the study. Abstinence of sexual intercourse is an acceptable method of birth control if it is used continuously for the duration of the study.
- •5. Ability to participate, willingness to give written informed consent, and willingness to comply with the study restrictions.
排除标准
- •1. Have taken, with 4 weeks of Screening or Intake, any of the following:
- •Selective Serotonin Reuptake Inhibitors (SSRIs)
- •Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs).
- •MAO-A inhibitors
- •Another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication (example: dihydroergotamine or methysergide), including St John’s wort
- •2. Are taking cimetidine and are unable to discontinue use of cimetidine from Screening until the End of Study.
- •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 >/=140mmHg (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. Diagnosed with, or clinical history of migraines, with or without aura reported at screening.
- •10. Known history of alcohol use disorder or other substance use disorder within 6 months prior to Screening.
- •11. Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening.
- •12. Pregnant or lactating female participants.
- •13. History of galactose intolerance (i.e., Lapp lactase deficiency or glucose-galactose malabsorption).
- •14. 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.
- •15. Participated in the Phase 1 Pharmacokinetic Multiple Ascending Dose study (MAP-ZOL-HV-001).
- •16. Other medical or psychiatric condition which, in the opinion of the Investigator, would place the participant 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.
- •17. Unwillingness or inability to comply with the study protocol, (including abstaining from all tobacco products during the dosing period and following a strict diet regime), for any other reason.
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