HealthyPhase 1NCT07056517
Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults
A Phase 1 study testing M107 and Duvie - Cohort 1, M107 - Cohort 2 and M107 - Cohort 3 in people with Healthy, run by Aclipse Two Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- M107 and Duvie - Cohort 1, M107 - Cohort 2 and M107 - Cohort 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Jul 2025to 22 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-label, Pharmacokinetics Study of Lobeglitazone From M107 ODT and Duvie® Under Fasted and Fed Conditions in Healthy Adults
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- M107 and Duvie - Cohort 1, M107 - Cohort 2, M107 - Cohort 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M107 and Duvie - Cohort 1Drug
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 - Cohort 2Drug
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 - Cohort 3Drug
Dosage form - Orally disintegrating tablet Dosage - 1.2 mg Participants will receive a single oral dose of M107 under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: M107 - Cohort 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From pre-dose to 48 hours post-dose.
Secondary outcomes (6)
Effect of food on maximum observed plasma concentration (Cmax) of Lobeglitazone
To compare the peak plasma concentration of Lobeglitazone after administration of M107 Orally Disintegrating Tablet under fasted versus fed conditions.
Measured: From pre-dose to 48 hours post-dose
Effect of food on time to maximum observed plasma concentration (Tmax) of Lobeglitazone
To assess the difference in time to reach peak plasma concentration under fasted versus fed conditions following administration of M107 Orally Disintegrating Tablet.
Measured: From pre-dose to 48 hours post-dose
Effect of food on total drug exposure (AUC0-last and AUCinf)
To evaluate the area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) and extrapolated to infinity (AUCinf) for Lobeglitazone under fasted versus fed conditions.
Measured: From pre-dose to 48 hours post-dose
Effect of food on terminal elimination half-life (t½)
To compare the terminal elimination half-life of Lobeglitazone under fasted and fed conditions following administration of M107 Orally Disintegrating Tablet.
Measured: From pre-dose to 48 hours post-dose
Effect of food on apparent oral clearance (CL/F) and volume of distribution (Vz/F)
To evaluate differences in oral clearance and volume of distribution of Lobeglitazone when M107 Orally Disintegrating Tablet is administered under fed versus fasted conditions.
Measured: From pre-dose to 48 hours post-dose
Effect of food on terminal elimination rate constant (λz or Kel) of lobeglitazone
To compare the terminal elimination rate constant (λz or Kel) of lobeglitazone under fasted and fed conditions following administration of the M107 Orally Disintegrating Tablet.
Measured: From pre-dose to 48 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start11 Jul 2025
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclipse Two Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056517
- Sponsor's protocol ID
- M107-C101
- Status last verified
- Apr 2026
- First submitted
- 30 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-label, Pharmacokinetics Study of Lobeglitazone From M107 ODT and Duvie® Under Fasted and Fed Conditions in Healthy Adults
- ClinicalTrials.gov ID
- NCT07056517
- Acronym / sponsor ID
- M107-C101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aclipse Two Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M107-C101 Cohort 1 | Experimental | Drug: M107 and Duvie - Cohort 1Participants 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. |
| M107-C101 Cohort 2 | Experimental | Drug: M107 - Cohort 2Participants 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. |
| M107-C101 Cohort 3 | Experimental | Drug: M107 - Cohort 3Participants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M107 and Duvie - Cohort 1Dosage 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. | Drug | M107-C101 Cohort 1 |
| M107 - Cohort 2Dosage 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. | Drug | M107-C101 Cohort 2 |
| M107 - Cohort 3Dosage form - Orally disintegrating tablet Dosage - 1.2 mg Participants will receive a single oral dose of M107 under fasted conditions. | Drug | M107-C101 Cohort 3 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormalities
Time frame: From screening to follow-up (up to Day 15 post-dose)
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.
Maximum observed plasma concentration (Cmax)
Time frame: From pre-dose to 48 hours post-dose
To determine the peak plasma concentration of Lobeglitazone following oral administration of M107 Orally Disintegrating Tablet and Duvie.
Time to maximum observed plasma concentration (Tmax)
Time frame: From pre-dose to 48 hours post-dose
To assess the time it takes to reach the maximum plasma concentration of Lobeglitazone after administration.
Last measurable plasma concentration (Clast)
Time frame: From pre-dose to 48 hours post-dose
To evaluate the last quantifiable concentration of Lobeglitazone detected in plasma following administration.
Time of last measurable plasma concentration (Tlast)
Time frame: From pre-dose to 48 hours post-dose
To determine the time at which the last quantifiable plasma concentration of Lobeglitazone is observed.
Area under the concentration-time curve from 0 to 24 hours (AUC0-24h)
Time frame: From pre-dose to 24 hours post-dose
To evaluate the extent of Lobeglitazone exposure over the first 24 hours post-dose.
Area under the concentration-time curve from 0 to last measurable concentration (AUC0-last)
Time frame: From pre-dose to 48 hours post-dose
To assess the total plasma exposure to Lobeglitazone from dosing until the last quantifiable concentration.
Area under the concentration-time curve extrapolated to infinity (AUCinf)
Time frame: From pre-dose to 48 hours post-dose
To estimate total drug exposure by including the extrapolated portion of the concentration-time curve.
Percentage of AUC extrapolated (%AUCexp)
Time frame: From pre-dose to 48 hours post-dose
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).
Terminal elimination half-life (t½)
Time frame: From pre-dose to 48 hours post-dose
To determine the time required for the plasma concentration of Lobeglitazone to decrease by half during the terminal elimination phase.
Apparent oral clearance (CL/F)
Time frame: From pre-dose to 48 hours post-dose
To assess the rate at which Lobeglitazone is eliminated from the plasma after oral administration.
Apparent volume of distribution (Vz/F)
Time frame: From pre-dose to 48 hours post-dose
To calculate the apparent volume in which Lobeglitazone is distributed throughout the body after oral administration.
Terminal elimination rate constant (λz or Kel)
Time frame: From pre-dose to 48 hours post-dose.
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.
6 secondary outcomes
Effect of food on maximum observed plasma concentration (Cmax) of Lobeglitazone
Time frame: From pre-dose to 48 hours post-dose
Effect of food on time to maximum observed plasma concentration (Tmax) of Lobeglitazone
Time frame: From pre-dose to 48 hours post-dose
Effect of food on total drug exposure (AUC0-last and AUCinf)
Time frame: From pre-dose to 48 hours post-dose
Effect of food on terminal elimination half-life (t½)
Time frame: From pre-dose to 48 hours post-dose
Effect of food on apparent oral clearance (CL/F) and volume of distribution (Vz/F)
Time frame: From pre-dose to 48 hours post-dose
Effect of food on terminal elimination rate constant (λz or Kel) of lobeglitazone
Time frame: From pre-dose to 48 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M107 and Duvie - Cohort 1, M107 - Cohort 2 and M107 - Cohort 3 in people with Healthy, run by Aclipse Two Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormalities (time frame: From screening to follow-up (up to Day 15 post-dose)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.