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Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

NCT07056517 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • Aclipse Two Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2025-09-22
Completion
2025-09-22

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07056517 on ClinicalTrials.gov