Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 11, 2025

Primary Completion Date

September 2, 2025

Study Completion Date

September 2, 2025

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.

Trial Locations (1)

3004

RECRUITING

Nucleus Network Pty Ltd., Melbourne

All Listed Sponsors
lead

Aclipse Two Inc.

INDUSTRY