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

Exclusion Criteria16

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Treatment with an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Known allergy to the investigational product or any of its components.
• Participants have donated or received any blood or blood products within 3 months prior to dosing.
• 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.
• Unwilling to refrain from alcohol consumption from 48 hours prior to investigational product administration and during the confinement periods.
• 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.
• Unwilling to avoid heavy exercise (eg, marathon runners, weightlifters) from 48 hours prior to investigational product administration and during the confinement periods.
• 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.
• 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.