NCT06268145

ECC5004 RBA FE Study in Healthy Participants

An Open-Label, Randomized, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Current Tablet Formulation (F1) Compared to New Tablet Formulation (F2) of ECC5004 and Food Effects on F1 and F2 of ECC5004 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Eccogene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants

Detailed description

Eligible participants will be randomized to one of the two fixed treatment sequences with four treatment periods. In the first two treatment periods under fasted conditions, participants will fast for a minimum of 10 hours, then they will receive a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2. In the subsequent third and fourth treatment periods under fed conditions, participants will consume completely a high fat breakfast followed by administration of a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ECC5004	A single dose tablet of 50 mg of the current tablet formulation (F1) or new tablet formulation (F2) administered orally.

Timeline

• Start date: 2024-02-06
• Primary completion: 2024-03-29
• Completion: 2024-03-29
• First posted: 2024-02-20
• Last updated: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study