A Study to Evaluate EDG-7500 in People With Renal Impairment

Part of paid clinical trials in Miami, Florida.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT07034768
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairments

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
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 kidney function impairment versus participants with normal kidney function. The safety of EDG-7500 in participants with different levels of kidney function impairment will also be evaluated in this study.

Key Dates

Start date
Jul 22, 2025
Status verified
Aug 2025
Primary completion
Dec 22, 2025
Completion
Dec 26, 2025

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Healthy Volunteers
  • Experimental: Severe Renal Impairment
  • Experimental: Moderate Renal Impairment
  • Experimental: Mild Renal Impairment
    This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment

Primary Outcome Measure

Area under the curve from time zero to last quantifiable concentration (AUC0-last) [ Time Frame: Pre-dose to day 11 ]

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Miami Division of Clinical PharmacologyMiamiFlorida33136-
Orlando Clinical Research CenterOrlandoFlorida32809-

Find similar trials in Miami, FL

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