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Kidney health may change how body handles cancer drug

NCT ID NCT05469100

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at how the body processes the drug selpercatinib (LOXO-292) in people with different levels of kidney function. Researchers gave a single dose to 37 volunteers—some with healthy kidneys and some with kidney impairment—and measured drug levels in the blood and urine over 9 days. The goal was to see if kidney problems change how much drug stays in the body or how fast it is removed, which could guide future dosing recommendations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Selpercatinib (also known as LOXO-292)
What this could lead to
If successful, this study could help doctors determine the right dose of selpercatinib for patients with kidney problems, making the drug safer and more effective for them.
What could go wrong
This is an early-phase, small study (37 participants) focused on drug levels, not on treating a disease. Results may not apply to all patients or predict real-world outcomes.

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

Dec 2018

Finished

Aug 2019

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 70 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.

Inclusion Criteria: For all participants: * Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study * Female of non childbearing potential: must have undergone sterilization procedures at least 6 months prior to the Screening * Males who are capable of fathering a child must agree to use contraception from the time of the dose administration through 6 months after the last dose For renal participants: * Participant has stable renal disease status and function at least 1 month prior to LOXO-292 administration. * Participant is not currently or has not previously being on hemodialysis * Baseline estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease (MDRD) equation at screening as follows: * Severe Renal Impairment (RI): \< 30 milliliter per minute (mL/min)/1.73m² * Moderate RI: ≥ 30 and \< 60 mL/min/1.73m² * Mild RI: ≥ 60 and \< 90 mL/min/1.73m² The MDRD equation is as follows (for females multiply result by 0.742, if African American multiply result by 1.212): eGFR = 175 x \[serum creatinine in milligrams per deciliter (mg/dL) measured with a standardized assay\]\^-1.154 x (Age)\^-0.203 Exclusion Criteria: For renal participants: * Has rapidly fluctuating renal function, as determined by historical measurements; or has demonstrated or suspected renal artery stenosis. Rapidly fluctuating renal function is defined as creatinine clearance or eGFR that differs by more than 20% within at least 3 months of the screening creatinine clearance or eGFR. If historical measurements are not available, then the 2 screening measurements will be used to demonstrate stability. * Participants who have had a renal transplant, a nephrectomy, or participants with a known history of nephrotic syndrome. * Participants who have required new medication for renal disease within 30 days prior to Check-in

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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

  • Anaheim Regional Center

    Anaheim, California, 92801, United States

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014, United States

  • Orange County Research Center

    Tustin, California, 92780, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • Riverside Clinical Research

    Edgewater, Florida, 32132, United States

  • Stanford Health Care, Valley Care Program

    Pleasanton, California, 94588, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.