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RECRUITING
NCT07056517
PHASE1

Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

Sponsor: Aclipse Two Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-07-11

Completion Date

2025-09-02

Last Updated

2025-07-28

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (1)

Nucleus Network Pty Ltd.

Melbourne, Victoria, Australia