ACTRN12624000833561尚未招募1 期
A Phase 1, Single Centre, Open Label, Single Dose, Food Effect, Cross Over Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers
Topelia Aust Ltd0 个研究点目标入组 8 人开始时间: 2024年7月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
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 60 Years（—）
- 性别
- All
入选标准
- •1. Healthy Volunteers
- •2. Male or Female
- •3. BMI 18.0-35.0 kg/m2,
- •4. Weight >50kgs
- •5. HREC worded Contraception for both males and females. Including male partners.; 1. Healthy Volunteers
- •2. Male or Female
- •3. BMI 18.0-35.0 kg/m2,
- •4. Weight >50kgs
- •5. HREC worded Contraception for both males and females. Including male partners.
排除标准
- •1. Presence or history of any cardiovascular, gastrointestinal, renal, hepatic, respiratory, hematological, immunological, dermatological, neurological, or psychiatric/psychological condition, which is considered to be clinically significant by the investigator or delegate.
- •2. Any concomitant disease or condition that could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the participant.
- •3. Normal hematologic and hepatic function defined as liver function tests = 1.5 x upper limit of normal and estimated glomerular filtration rate > 59 and determined by clinical lab results. Repeat tests may be conducted at the discretion of the investigator.
- •4. Clinically relevant abnormal laboratory results, 12-lead electrocardiogram (ECG) and vital signs, or physical findings at screening and/or Day -1 as judged by the investigator. Tests performed during screening may be repeated once at the discretion of the investigator to confirm eligibility.
- •5. Use of prescription medication 14 days prior to dosing on Day 1 until the end of study (EOS) visit. Exceptions are hormone replacement therapy and contraception. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
- •6. Use of over-the-counter medications in the 7 days or 5 half-lives before dosing on Day 1 until the EOS visit. Exceptions are paracetamol (up to 2 gm/day) and vitamins. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
- •7. Active COVID-19 infection or COVID-19 infection within the last 3 months prior to screening. Long COVID-19 not resolved for longer than 3 months.
- •8. Treatment with an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening.
- •9. Known allergy to the investigational product or any of its components.
- •10. Participants have donated or received any blood or blood products within 3 months prior to dosing.
- •11. Unwilling to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration and during the confinement periods.
- •12. Unwilling to refrain from alcohol consumption from 48 hours prior to investigational product administration and during the confinement periods.
- •13. Unwilling to refrain from consuming caffeine/xanthine beverages or food (tea, coffee, chocolate), from 48 hours prior to investigational product administration and during the confinement periods.
- •14. Unwilling to avoid heavy exercise (eg, marathon runners, weightlifters) from 48 hours prior to investigational product administration and during the confinement periods.
- •15. Unwilling to refrain from use of nicotine containing products from 48 hours prior to investigational product administration and during the confinement period/s. Products approved for smoking cessation such as nicotine patches, gum and lozenges may be allowed throughout the study at the investigator’s discretion.
- •16. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the study or result in incomplete or poor-quality data.; 1. Presence or history of any cardiovascular, gastrointestinal, renal, hepatic, respiratory, hematological, immunological, dermatological, neurological, or psychiatric/psychological condition, which is considered to be clinically significant by the investigator or delegate.
- •2. Any concomitant disease or condition that could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the participant.
- •3. Normal hematologic and hepatic function defined as liver function tests = 1.5 x upper limit of normal and estimated glomerular filtration rate > 59 and determined by clinical lab results. Repeat tests may be conducted at the discretion of the investigator.
- •4. Clinically relevant abnormal laboratory results, 12-lead electrocardiogram (ECG) and vital signs, or physical findings at screening and/or Day -1 as judged by the investigator. Tests performed during screening may be repeated once at the discretion of the investigator to confirm eligibility.
- •5. Use of prescription medication 14 days prior to dosing on Day 1 until the end of study (EOS) visit. Exceptions are hormone replacement therapy and contraception. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
- •6. Use of over-the-counter medications in the 7 days or 5 half-lives before dosing on Day 1 until the EOS visit. Exceptions are paracetamol (up to 2 gm/day) and vitamins. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
- •7. Active COVID-19 infection or COVID-19 infection within the last 3 months prior to screening. Long COVID-19 not resolved for longer than 3 months.
- •8. Treatment with an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening.
- •9. Known allergy to the investigational product or any of its components.
- •10. Participants have donated or received any blood or blood products within 3 months prior to dosing.
- •11. Unwilling to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration and during the confinement periods.
- •12. Unwilling to refrain from alcohol consumption from 48 hours prior to investigational product administration and during the confinement periods.
- •13. Unwilling to refrain from consuming caffeine/xanthine beverages or food (tea, coffee, chocolate), from 48 hours prior to investigational product administration and during the confinement periods.
- •14. Unwilling to avoid heavy exercise (eg, marathon runners, weightlifters) from 48 hours prior to investigational product administration and during the confinement periods.
- •15. Unwilling to refrain from use of nicotine containing products from 48 hours prior to investigational product administration and during the confinement period/s. Products approved for smoking cessation such as nicotine patches, gum and lozenges may be allowed throughout the study at the investigator’s discretion.
- •16. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the study or result in incomplete or poor-quality data.
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