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NOT YET RECRUITING
NCT07873229
PHASE1

DDI Study of ECC0509 With Metformin, Midazolam, and Caffeine

Sponsor: Eccogene

View on ClinicalTrials.gov

Summary

This is a Phase 1, open-label, 2-part, fixed-sequence, single-center, two-period, drug-drug interaction trial in healthy adult participants to determine if ECC0509 administration at steady state affects the pharmacokinetics (PK) of metformin (a MATE1/2-K probe substrate), midazolam (a CYP3A4 probe substrate), and caffeine (a CYP1A2 probe substrate).

Official title: A Phase 1, Open-Label, Fixed-Sequence, Single-Center, Two-Period, Drug-Drug Interaction Trial in Healthy Adult Participants to Evaluate the Effect of Steady-State ECC0509 on the Pharmacokinetics of Metformin (MATE1/2-K Probe Substrate), Midazolam (CYP3A4 Probe Substrate), and Caffeine (CYP1A2 Probe Substrate)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11

Completion Date

2027-04

Last Updated

2026-10-14

Healthy Volunteers

Yes

Interventions

DRUG

ECC0509

ECC0509 will be administered orally.

DRUG

Metformin

Metformin will be administered orally.

DRUG

Caffeine

Caffeine will be administered orally.

DRUG

Midazolam

Midazolam will be administered orally.

Locations (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia