Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

Exclusion Criteria15

• Pregnant or breastfeeding females, or individuals (male or female) actively trying to conceive.
• History of drug or alcohol use disorder within the past 2 years.
• Active smoker or user of nicotine products (>5 cigarettes/week) or positive cotinine test at admission.
• Difficulty with venipuncture or history of coagulopathy/endocarditis.
• Significant history of cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, endocrine, hematologic, or psychiatric disorders.
• History of malignancy not in complete remission for at least 5 years (except localized basal/squamous cell skin cancer or prostate cancer deemed controlled).
• Use of any prescription or over-the-counter medication, vitamins, or herbal supplements within 14 days or 5 half-lives prior to screening.
• Use of any prescription medication, over-the-counter medication, or herbal supplements (other than permitted contraceptives or as approved by the investigator) from Screening until completion of the study.
• Elevated resting blood pressure (systolic >140 mmHg or diastolic >90 mmHg) or heart rate >100 bpm.
• History of major surgery within 4 weeks or minor surgery within 2 weeks of dosing.
• Recent flu-like illness or respiratory infection within 2 weeks, or recent live-virus vaccination within 4 weeks of dosing.
• Clinically significant ECG abnormalities including QTcF >450 ms, 2nd/3rd degree atrioventricular block, or incomplete left hemiblock.
• Known bleeding disorders or history of significant allergic reaction to any drug component used in the study.
• Blood or plasma donation >500 mL within 30 days before screening.
• Any other condition which, in the opinion of the investigator, would preclude safe participation.