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
Recruiting
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Conditions

  • Hepatic Impairment (HI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • EDG-7500 — DRUG
    Single 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

Start date
Jan 26, 2026
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
32 participants (estimated)
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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Miami Division of Clinical PharmacologyMiamiFlorida33136
Edgewise Therapeutics, Inc.
[email protected]
720-262-7002
Orlando Clinical Research CenterOrlandoFlorida32809
Edgewise Therapeutics, Inc.
[email protected]
720-262-7002

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By research site
The University of Miami Division of Clinical Pharmacology· Miami, FLOrlando Clinical Research Center· Orlando, FL

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