Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

Launched by ACLIPSE TWO INC. · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is a first-step study looking at how a new form of a medicine called lobeglitazone, given as a tablet that dissolves in the mouth, behaves in the body and whether it is safe for healthy adults. The study compares this new tablet with another form of the medicine to see how the body absorbs and processes them when taken with or without food. This helps researchers understand how the medicine works before testing it in people with health conditions.

Healthy men and women between 18 and 55 years old who meet certain health standards may be able to join. Participants need to have a body weight of at least 50 kg (about 110 pounds), a body mass index (BMI) within a normal range, and not smoke or use nicotine products. Women must either not be able to have children or agree to use birth control during the study. Those who join will be asked to avoid alcohol, caffeine, grapefruit products, and heavy exercise during the study. The trial will carefully monitor participants’ health through exams and tests to make sure the medicine is safe and well-tolerated. This study is not yet recruiting participants but aims to gather important safety information for future research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male and female participants aged 18 to 55 years (inclusive) at the time of informed consent.
• • 2. Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening.
• • 3. Body weight ≥50 kg at Screening.
• • 4. Capable of giving informed consent and complying with study procedures.
• • 5. Female participants must be of non-childbearing potential (postmenopausal or surgically sterile) or, if of childbearing potential, must agree to use acceptable contraception.
• • 6. Participants must be non-smokers and must not have used any nicotine-containing products within 30 days prior to Screening and throughout the study.
• • 7. Normal findings in physical examination, clinical laboratory tests, vital signs, and ECG, or findings considered not clinically significant by the investigator.
• • 8. Willing to abstain from alcohol, grapefruit products, and caffeine as per study restrictions.
• • 9. Willing to refrain from strenuous physical activity as specified in the protocol.
• • 10. Male participants must agree to use contraception and avoid sperm donation during the study and for a specified period after.
• • 11. 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:
• • 1. Pregnant or breastfeeding females, or individuals (male or female) actively trying to conceive.
• • 2. History of drug or alcohol use disorder within the past 2 years.
• • 3. Active smoker or user of nicotine products (\>5 cigarettes/week) or positive cotinine test at admission.
• • 4. Difficulty with venipuncture or history of coagulopathy/endocarditis.
• • 5. Significant history of cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, endocrine, hematologic, or psychiatric disorders.
• • 6. History of malignancy not in complete remission for at least 5 years (except localized basal/squamous cell skin cancer or prostate cancer deemed controlled).
• • 7. Use of any prescription or over-the-counter medication, vitamins, or herbal supplements within 14 days or 5 half-lives prior to screening.
• • 8. 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.
• • 9. Elevated resting blood pressure (systolic \>140 mmHg or diastolic \>90 mmHg) or heart rate \>100 bpm.
• • 10. History of major surgery within 4 weeks or minor surgery within 2 weeks of dosing.
• • 11. Recent flu-like illness or respiratory infection within 2 weeks, or recent live-virus vaccination within 4 weeks of dosing.
• • 12. Clinically significant ECG abnormalities including QTcF \>450 ms, 2nd/3rd degree atrioventricular block, or incomplete left hemiblock.
• • 13. Known bleeding disorders or history of significant allergic reaction to any drug component used in the study.
• • 14. Blood or plasma donation \>500 mL within 30 days before screening.
• • 15. Any other condition which, in the opinion of the investigator, would preclude safe participation.