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DDI Study of ECC0509 With Metformin, Midazolam, and Caffeine
Sponsor: Eccogene
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
ECC0509
ECC0509 will be administered orally.
Metformin
Metformin will be administered orally.
Caffeine
Caffeine will be administered orally.
Midazolam
Midazolam will be administered orally.
Locations (1)
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia