Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

PHASE1COMPLETED

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Exclusion criteria

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE1

Study ID

NCT07056517

Intervention or treatment

DRUG: M107 and Duvie - Cohort 1

DRUG: M107 - Cohort 2

DRUG: M107 - Cohort 3

Conditions

Healthy

Condition: Healthy
DRUG: M107 and Duvie - Cohort 1 and other drugs
Melbourne, Victoria, Australia
Sponsor: Aclipse Two Inc.

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Research sites nearby

Closest Location:

Nucleus Network Pty Ltd.

Select from list below to view details:

Nucleus Network Pty Ltd.
Melbourne, Victoria, Australia

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Who is running the clinical trial?

ATI

Aclipse Two Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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. Up to 8 participants are expected to enroll in this cohort.	Drug: M107 and Duvie - Cohort 1
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. Up to 8 participants are expected to enroll in this cohort.	Drug: M107 - Cohort 2
EXPERIMENTAL: M107-C101 Cohort 3 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

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
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 Outcome

Measure	Description	Time Frame
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.	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.	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.	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.	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.	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.	From pre-dose to 48 hours post-dose.

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References

Clinical Trials Gov: Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

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