DDI Study of ECC0509 With Metformin, Midazolam, and Caffeine

Prior treatment

• Has a history of drug abuse within the previous 2 years, or a positive drug screen at Screening and/or Day -1.
• History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.

Other illness

• Has a history of significant renal, hepatic, cardiovascular, psychiatric, neoplastic, thyroid disease/abnormality or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the trial.
• Has a history of sensitivity to any of the trial treatments (and/or their excipients), or severe drug or other allergy
• Has a history or current diagnosis of a significant psychiatric disorder that would, in the opinion of the Investigator, affect the participant's ability to comply with the trial requirements.
• Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication.
• Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

Lab values

• History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known pathological arrythmia.

Other

• Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day.
• Has excessively consumed beverages/products containing caffeine for the past month (more than 2 cups or glasses a day) or is unable to stop or limit consumption during the trial.

• Male or female between the ages of 18 and 65 years, inclusive, at the time of Screening.
• Are healthy and in the opinion of the Investigator have an acceptable medical history (free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological, infective, or psychiatric diseases as determined by medical history over the past 5 years, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests).
• Has not consumed and agrees to abstain from taking any prescription drugs or non-prescription drugs for 7 days or 5 half-lives (whichever is longer) prior to first dose of trial treatment and continuing through end of the Treatment Period.