Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

Aclipse Two Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: M107 - Cohort 2; Drug: M107 and Duvie - Cohort 1; Drug: M107 - Cohort 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT07056517

M107-C101

Details and patient eligibility

About

Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of lobeglitazone administered as M107 Orally Disintegrating Tablet and Duvie tablet in healthy adult participants under fasted and fed conditions.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

M107-C101 Cohort 1

Experimental group

Description:

Participants will receive a single oral dose of either Duvie (0.415 milligrams) or M107 Orally Disintegrating Tablet (0.4 milligrams) under fasted conditions on Day 1, followed by the alternate treatment on Day 8 after a 7-day washout. 8 participants are expected to enroll in this cohort.

Treatment:

Drug: M107 and Duvie - Cohort 1

M107-C101 Cohort 2

Experimental group

Description:

Participants will receive a single 0.8 milligram oral dose of M107 Orally Disintegrating Tablet under fasted conditions on Day 1 and under fed conditions on Day 8, following a 7-day washout. 8 participants are expected to enroll in this cohort.

Treatment:

Drug: M107 - Cohort 2

M107-C101 Cohort 3

Experimental group

Description:

Participants will receive a single 1.2 milligram dose of M107 Orally Disintegrating Tablet under fasted conditions. 8 participants are expected to enroll in this cohort.

Treatment:

Drug: M107 - Cohort 3