Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

NCT07056517 | Completed Phase 1

• 1 other identifier: M107-C101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (13)

• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormalities

  To assess the frequency and severity of TEAEs, SAEs, and any clinically significant changes in laboratory parameters, vital signs, electrocardiogram, and physical examination findings following administration of M107 Orally Disintegrating Tablet and Duvie.

  From screening to follow-up (up to Day 15 post-dose)

• Maximum observed plasma concentration (Cmax)

  To determine the peak plasma concentration of Lobeglitazone following oral administration of M107 Orally Disintegrating Tablet and Duvie.

  From pre-dose to 48 hours post-dose

• Time to maximum observed plasma concentration (Tmax)

  To assess the time it takes to reach the maximum plasma concentration of Lobeglitazone after administration.

  From pre-dose to 48 hours post-dose

• Last measurable plasma concentration (Clast)

  To evaluate the last quantifiable concentration of Lobeglitazone detected in plasma following administration.

  From pre-dose to 48 hours post-dose

• Time of last measurable plasma concentration (Tlast)

  To determine the time at which the last quantifiable plasma concentration of Lobeglitazone is observed.

  From pre-dose to 48 hours post-dose

• Area under the concentration-time curve from 0 to 24 hours (AUC0-24h)

  To evaluate the extent of Lobeglitazone exposure over the first 24 hours post-dose.

  From pre-dose to 24 hours post-dose

• Area under the concentration-time curve from 0 to last measurable concentration (AUC0-last)

  To assess the total plasma exposure to Lobeglitazone from dosing until the last quantifiable concentration.

  From pre-dose to 48 hours post-dose

• Area under the concentration-time curve extrapolated to infinity (AUCinf)

  To estimate total drug exposure by including the extrapolated portion of the concentration-time curve.

  From pre-dose to 48 hours post-dose

• Percentage of AUC extrapolated (%AUCexp)

  Percentage of the total area under the plasma concentration-time curve from time zero to infinity (AUC₀-inf) that is extrapolated beyond the last measurable concentration (%AUCexp).

  From pre-dose to 48 hours post-dose

• Terminal elimination half-life (t½)

  To determine the time required for the plasma concentration of Lobeglitazone to decrease by half during the terminal elimination phase.

  From pre-dose to 48 hours post-dose

• Apparent oral clearance (CL/F)

  To assess the rate at which Lobeglitazone is eliminated from the plasma after oral administration.

  From pre-dose to 48 hours post-dose

• Apparent volume of distribution (Vz/F)

  To calculate the apparent volume in which Lobeglitazone is distributed throughout the body after oral administration.

  From pre-dose to 48 hours post-dose

• Terminal elimination rate constant (λz or Kel)

  To estimate the terminal elimination rate constant (λz or Kel) from the log-linear terminal phase of the plasma concentration-time curve following oral administration of lobeglitazone.

  From pre-dose to 48 hours post-dose.

Secondary Outcomes (6)

• Effect of food on maximum observed plasma concentration (Cmax) of Lobeglitazone

  From pre-dose to 48 hours post-dose

• Effect of food on time to maximum observed plasma concentration (Tmax) of Lobeglitazone

  From pre-dose to 48 hours post-dose

• Effect of food on total drug exposure (AUC0-last and AUCinf)

  From pre-dose to 48 hours post-dose

• Effect of food on terminal elimination half-life (t½)

  From pre-dose to 48 hours post-dose

• Effect of food on apparent oral clearance (CL/F) and volume of distribution (Vz/F)

  From pre-dose to 48 hours post-dose

Study Arms (3)

M107-C101 Cohort 1

EXPERIMENTAL

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. Up to 8 participants are expected to enroll in this cohort.

Drug: M107 and Duvie - Cohort 1

M107-C101 Cohort 2

EXPERIMENTAL

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. Up to 8 participants are expected to enroll in this cohort.

Drug: M107 - Cohort 2

M107-C101 Cohort 3

EXPERIMENTAL

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

Drug: M107 - Cohort 3

Interventions

M107 and Duvie - Cohort 1 DRUG

Dosage form - Oral tablets Dosage - Duvie 0.415 mg and M107 ODT 0.4 mg Participants will receive each treatment once under fasted conditions in a randomized two-period crossover design.

M107-C101 Cohort 1

M107 - Cohort 2 DRUG

Dosage form - Orally disintegrating tablet Dosage - 0.8 mg Participants will receive M107 once under fasted conditions and once after a high-fat, high-calorie meal in a two-period crossover design.

M107-C101 Cohort 2

M107 - Cohort 3 DRUG

Dosage form - Orally disintegrating tablet Dosage - 1.2 mg Participants will receive a single oral dose of M107 under fasted conditions.

M107-C101 Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aclipse Two Inc.: lead

Study Sites (1)

Nucleus Network Pty Ltd.

Melbourne, Victoria, 3004, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: July 11, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)