A First-in-human Trial of GRT7041 in Healthy Participants

Exclusion Criteria11

• History of any of the following: cardiac impairment, renal impairment, pancreatitis, coagulation abnormalities.
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk for treatment complications/ participation in the trial unsafe.
• Any disease or conditions known to interfere with the absorption, distribution, metabolism, or excretion of the IMP.
• Evidence or medical history of clinically significant and relevant psychiatric issues as assessed by the Investigator.
• Confirmed or suspected history of clinically relevant drug allergy.
• Major surgical procedure, within 30 days prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.
• Blood loss of 500 mL or more (eg, owing to blood donation) within 90 days before Screening Visit.
• The participant has used any medication, including herbal remedies or over-the-counter medication within 2 weeks (or 5 half-lives, whichever is longer) before the start of the trial intervention or anticipated use during the trial, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial.
• The participant is enrolled in another clinical trial unless it is an observational (non-interventional) clinical trial or during the follow-up period of an interventional trial) or has received an IMP in another clinical trial within 30 days before Day 1 or within 5 times the elimination half-life of the IMP, whichever is longer.
• Reluctance to comply with contraception requirements.
• Evidence or history of alcohol or drug abuse including positive or missing alcohol breath test or drugs of abuse test(s).