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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental |
| |
| Severe Renal Impairment | Experimental |
| |
| Moderate Renal Impairment | Experimental |
| |
| Mild Renal Impairment | Experimental | This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDG-7500 | Drug | Single dose of EDG-7500 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time zero to last quantifiable concentration (AUC0-last) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-last) | Pre-dose to day 11 |
| Area under the curve from time zero to extrapolated infinite time (AUC0-inf) | Area under the plasma concentration time-curve from zero to extrapolated infinite time (AUC0-inf) | Pre-dose to day 11 |
| Maximum observed plasma concentration (Cmax) | Pre-dose to day 11 | |
| Observed plasma concentration at the end of the dosing interval (C24) | Pre-dose to day 11 | |
| Time to reach maximum observed plasma concentration (Tmax) | Pre-dose to day 11 | |
| Plasma elimination half-life (T1/2) | The time measured for the plasma concentration to decrease by one half. | Pre-dose to day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of unchanged drug excreted in urine from zero to 24 hours post dose (Ae0-24) | From day -1 to day 11 | |
| Fraction of drug excreted unchanged in urine (fe) | From day -1 to day 11 | |
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Key Inclusion Criteria:
All Participants
Participants with Severe, Moderate and Mild Renal Impairment (RI)
With the exception of RI and other stable diseases, participant is sufficiently healthy for study participation including the following:
Has impaired renal function as determined by eGFR:
Has stable renal function with no clinically significant change in renal status at least 28 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year.
Participants with Normal Renal Function
Medically healthy, including the following:
Exclusion Criteria:
All Participants
Participants with Severe, Moderate, and Mild RI (Cohorts 1, 2, and 4)
Participants with Normal Renal Function (Cohort 3)
-History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Miami Division of Clinical Pharmacology | Miami | Florida | 33136 | United States | ||
| Orlando Clinical Research Center |
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| Renal clearance |
| From day -1 to day 11 |
| Orlando |
| Florida |
| 32809 |
| United States |