A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Edgewise Therapeutics, Inc.
- Study ID
- NCT07324616
- Phase
- PHASE1
- Status
- Completed
Conditions
- Hepatic Impairment (HI)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- EDG-7500 — DRUGSingle dose of EDG-7500
Study Details
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of liver function impairment versus participants with normal liver function. The safety of EDG-7500 in adult participants with different levels of liver function impairment will also be evaluated in this study.
Key Dates
- First listed
- Jan 7, 2026
- Start date
- Jan 26, 2026
- Status verified
- Jul 2026
- Primary completion
- Apr 7, 2026
- Completion
- Apr 7, 2026
Study Design
- Enrollment
- 25 participants (actual)
- Allocation
- NA
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Healthy Adults
- Experimental: Mild Hepatic Impairment
- Experimental: Moderate Hepatic Impairment
Primary Outcome Measure
Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last) [ Time Frame: Pre-dose to day 10 ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Miami Division of Clinical Pharmacology | Miami | Florida | 33136 | - |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | - |