Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

This is a Phase 1, single-center, parallel group study designed to determine the single-dose safety and PK profile of lobeglitazone from M107 ODT and Duvie, both administered orally in healthy adult volunteers.

Participants will be enrolled in 1 of 3 cohorts conducted in parallel:

Cohort 1 (Crossover): A single dose of Duvie oral tablet (0.415 mg; fasted) on Day 1 followed by a single dose of M107 ODT (0.4 mg; fasted) on Day 8, or vice versa, based on their random assignment with a 7-day washout between each dose.

Cohort 2 (Crossover): M107 ODT (0.8 mg; fasted) followed by M107 ODT (0.8 mg; fed) after a 7-day washout.

Cohort 3: M107 ODT (1.2 mg fasted) Participants in this cohort will receive M107 ODT 1.2 mg after a 10-hour fast.

A total of up to 24 participants are planned to be enrolled, 8 in each cohort, in order to ensure 6 evaluable participants in each cohort. At least 2 males and 2 females are to be enrolled in each cohort.

Inclusion criteria

• Healthy male and female participants aged 18 to 55 years (inclusive) at the time of informed consent.
• Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening.
• Body weight ≥50 kg at Screening.
• Capable of giving informed consent and complying with study procedures.
• Female participants must be of non-childbearing potential (postmenopausal or surgically sterile) or, if of childbearing potential, must agree to use acceptable contraception.
• Participants must be non-smokers and must not have used any nicotine-containing products within 30 days prior to Screening and throughout the study.
• Normal findings in physical examination, clinical laboratory tests, vital signs, and ECG, or findings considered not clinically significant by the investigator.
• Willing to abstain from alcohol, grapefruit products, and caffeine as per study restrictions.
• Willing to refrain from strenuous physical activity as specified in the protocol.
• Male participants must agree to use contraception and avoid sperm donation during the study and for a specified period after.
• Female participants of childbearing potential must agree to refrain from egg donation during the study and for at least 30 days after the last dose of study drug.

Exclusion criteria

• 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.