Kidney function may affect drug levels: new study completed
NCT ID NCT07034768
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a single dose of the drug EDG-7500 stays in the blood of people with various levels of kidney function, from normal to severely impaired. It involved 37 adults aged 18-75. The goal was to understand if kidney problems change drug levels, which helps doctors decide on proper dosing.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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37 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: All Participants * Adult, male or female, 18-75 years of age, inclusive * Female and male participants must follow protocol-specified contraception guidance * Continuous non-smoker or light smoker (≤ 5 cigarettes per day or equivalent) for at least 3 months prior to dosing * BMI ≥ 18.0 and ≤ 40.0 kg/m2 at the screening visit. 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: * Heart rate ≥ 40 bpm and ≤ 110 bpm. * QTcF interval ≤ 500 msec and has ECG findings considered normal or not clinically significant. * Liver function test including ALT ≤ ULN, AST ≤ ULN, and total bilirubin ≤ 1.5 ULN * Has impaired renal function as determined by eGFR: * eGFR \<30 mL/min, not requiring hemodialysis, for participants with severe RI. * eGFR ≥30 but \<60 mL/min for participants with moderate RI. * eGFR ≥60 but \<90 mL/min for participants with mild RI. * 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: * Blood pressure ≥ 90/40 mmHg and ≤ 150/95 mmHg * Heart rate ≥ 40 bpm and ≤ 100 bpm * QTcF interval ≤ 470 msec and has ECG findings considered normal or not clinically significant * Liver function test including ALT ≤ ULN, AST ≤ ULN, and total bilirubin ≤1.5x ULN * Normal renal function with eGFR ≥ 90 mL/min Exclusion Criteria: All Participants * History or presence of alcohol or drug abuse within the past 2 years prior to dosing. * Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating. * Positive urine or breath alcohol results. Unable to refrain from or anticipates the use of any drugs. * Positive results for HIV, HBsAg, or HCV. * Donation of blood or significant blood loss within 56 days prior to the first dosing. * Plasma donation within 7 days prior to the first dosing. * Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to dosing. Participants with Severe, Moderate, and Mild RI (Cohorts 1, 2, and 4) * History or presence of renal artery stenosis. * Renal transplant or nephrectomy in ≤ 5 years. * Diabetes confirmed with HbA1c \> 8.5%. 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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The University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.