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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07056517
Registration number
NCT07056517
Ethics application status
Date submitted
30/06/2025
Date registered
9/07/2025
Date last updated
9/07/2025
Titles & IDs
Public title
Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults
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Scientific title
A Single-Dose, Open-label, Pharmacokinetics Study of Lobeglitazone From M107 ODT and Duvie® Under Fasted and Fed Conditions in Healthy Adults
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Secondary ID [1]
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M107-C101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - M107 and Duvie - Cohort 1
Treatment: Drugs - M107 - Cohort 2
Treatment: Drugs - M107 - Cohort 3
Experimental: M107-C101 Cohort 1 - 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.
Experimental: M107-C101 Cohort 2 - 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.
Experimental: M107-C101 Cohort 3 - 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: Drugs: M107 and Duvie - Cohort 1
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.
Treatment: Drugs: M107 - Cohort 2
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.
Treatment: Drugs: M107 - Cohort 3
Dosage form - Orally disintegrating tablet Dosage - 1.2 mg Participants will receive a single oral dose of M107 under fasted conditions.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormalities
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Assessment method [1]
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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.
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Timepoint [1]
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From screening to follow-up (up to Day 15 post-dose)
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Primary outcome [2]
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Maximum observed plasma concentration (Cmax)
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Assessment method [2]
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To determine the peak plasma concentration of Lobeglitazone following oral administration of M107 Orally Disintegrating Tablet and Duvie.
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Timepoint [2]
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From pre-dose to 48 hours post-dose
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Primary outcome [3]
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Time to maximum observed plasma concentration (Tmax)
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Assessment method [3]
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To assess the time it takes to reach the maximum plasma concentration of Lobeglitazone after administration.
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Timepoint [3]
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From pre-dose to 48 hours post-dose
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Primary outcome [4]
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Last measurable plasma concentration (Clast)
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Assessment method [4]
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To evaluate the last quantifiable concentration of Lobeglitazone detected in plasma following administration.
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Timepoint [4]
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From pre-dose to 48 hours post-dose
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Primary outcome [5]
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Time of last measurable plasma concentration (Tlast)
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Assessment method [5]
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To determine the time at which the last quantifiable plasma concentration of Lobeglitazone is observed.
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Timepoint [5]
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From pre-dose to 48 hours post-dose
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Primary outcome [6]
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Area under the concentration-time curve from 0 to 24 hours (AUC0-24h)
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Assessment method [6]
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To evaluate the extent of Lobeglitazone exposure over the first 24 hours post-dose.
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Timepoint [6]
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From pre-dose to 24 hours post-dose
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Primary outcome [7]
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Area under the concentration-time curve from 0 to last measurable concentration (AUC0-last)
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Assessment method [7]
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To assess the total plasma exposure to Lobeglitazone from dosing until the last quantifiable concentration.
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Timepoint [7]
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From pre-dose to 48 hours post-dose
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Primary outcome [8]
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Area under the concentration-time curve extrapolated to infinity (AUCinf)
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Assessment method [8]
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To estimate total drug exposure by including the extrapolated portion of the concentration-time curve.
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Timepoint [8]
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From pre-dose to 48 hours post-dose
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Primary outcome [9]
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Percentage of AUC extrapolated (%AUCexp)
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Assessment method [9]
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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).
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Timepoint [9]
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From pre-dose to 48 hours post-dose
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Primary outcome [10]
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Terminal elimination half-life (t½)
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Assessment method [10]
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To determine the time required for the plasma concentration of Lobeglitazone to decrease by half during the terminal elimination phase.
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Timepoint [10]
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From pre-dose to 48 hours post-dose
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Primary outcome [11]
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Apparent oral clearance (CL/F)
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Assessment method [11]
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To assess the rate at which Lobeglitazone is eliminated from the plasma after oral administration.
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Timepoint [11]
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From pre-dose to 48 hours post-dose
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Primary outcome [12]
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Apparent volume of distribution (Vz/F)
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Assessment method [12]
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To calculate the apparent volume in which Lobeglitazone is distributed throughout the body after oral administration.
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Timepoint [12]
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From pre-dose to 48 hours post-dose
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Primary outcome [13]
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Terminal elimination rate constant (?z or Kel)
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Assessment method [13]
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To estimate the terminal elimination rate constant (?z or Kel) from the log-linear terminal phase of the plasma concentration-time curve following oral administration of lobeglitazone.
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Timepoint [13]
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From pre-dose to 48 hours post-dose.
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Secondary outcome [1]
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Effect of food on maximum observed plasma concentration (Cmax) of Lobeglitazone
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Assessment method [1]
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To compare the peak plasma concentration of Lobeglitazone after administration of M107 Orally Disintegrating Tablet under fasted versus fed conditions.
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Timepoint [1]
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From pre-dose to 48 hours post-dose
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Secondary outcome [2]
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Effect of food on time to maximum observed plasma concentration (Tmax) of Lobeglitazone
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Assessment method [2]
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To assess the difference in time to reach peak plasma concentration under fasted versus fed conditions following administration of M107 Orally Disintegrating Tablet.
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Timepoint [2]
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From pre-dose to 48 hours post-dose
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Secondary outcome [3]
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Effect of food on total drug exposure (AUC0-last and AUCinf)
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Assessment method [3]
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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.
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Timepoint [3]
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From pre-dose to 48 hours post-dose
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Secondary outcome [4]
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Effect of food on terminal elimination half-life (t½)
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Assessment method [4]
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To compare the terminal elimination half-life of Lobeglitazone under fasted and fed conditions following administration of M107 Orally Disintegrating Tablet.
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Timepoint [4]
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From pre-dose to 48 hours post-dose
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Secondary outcome [5]
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Effect of food on apparent oral clearance (CL/F) and volume of distribution (Vz/F)
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Assessment method [5]
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To evaluate differences in oral clearance and volume of distribution of Lobeglitazone when M107 Orally Disintegrating Tablet is administered under fed versus fasted conditions.
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Timepoint [5]
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From pre-dose to 48 hours post-dose
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Secondary outcome [6]
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Effect of food on terminal elimination rate constant (?z or Kel) of lobeglitazone
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Assessment method [6]
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To compare the terminal elimination rate constant (?z or Kel) of lobeglitazone under fasted and fed conditions following administration of the M107 Orally Disintegrating Tablet.
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Timepoint [6]
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From pre-dose to 48 hours post-dose.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
8/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/09/2025
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network Pty Ltd. - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Aclipse Two Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07056517
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ira Kalfus
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Address
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Country
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Phone
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+19178177517
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07056517
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