Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adults | Experimental |
| |
| Mild Hepatic Impairment | Experimental |
| |
| Moderate Hepatic Impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDG-7500 | Drug | Single dose of EDG-7500 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last) | Pre-dose to day 10 | |
| Area under the plasma concentration time-curve from time zero extrapolated to infinity (AUC0-inf) | Pre-dose to day 10 | |
| Maximum observed plasma concentration (Cmax) | Pre-dose to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of treatment-emergent adverse events | To evaluate the safety and tolerability of a single oral dose of EDG-7500 in participants with mild and moderate hepatic impairment and participants with normal hepatic function | Up to 14 days of monitoring |
Not provided
Inclusion Criteria:
All Participants
Participants with Mild and Moderate Hepatic Impairment (HI)
With the exception of HI, is in generally good health for study participation including the following:
Has impaired hepatic function as defined by the Child-Pugh classification for severity of liver disease and has a Child-Pugh score in line with one of the following HI cohorts at screening:
Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency.
Participants with Normal Hepatic Function:
-Medically healthy, including the following:
Exclusion Criteria:
All Participants
Participants with Mild and Moderate HI
Participants with Normal Hepatic Function
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edgewise Therapeutics, Inc. | Contact | 720-262-7002 | cardiacstudies@edgewisetx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Miami Division of Clinical Pharmacology | Recruiting | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orlando Clinical Research Center | Recruiting | Orlando | Florida | 32809 | United States |
|