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Kidney function may affect drug levels: new study completed

NCT ID NCT07034768

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

37 people

The number who actually took part.

Started

Jul 2025

Finished

Dec 2025

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • 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.