NCT07056517

Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

A Single-Dose, Open-label, Pharmacokinetics Study of Lobeglitazone From M107 ODT and Duvie® Under Fasted and Fed Conditions in Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Aclipse Two Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	M107 - Cohort 3	Dosage form - Orally disintegrating tablet Dosage - 1.2 mg Participants will receive a single oral dose of M107 under fasted conditions.

Timeline

• Start date: 2025-07-11
• Primary completion: 2025-09-02
• Completion: 2025-09-02
• First posted: 2025-07-09
• Last updated: 2025-07-28

Locations

1 site across 1 country: Australia