Kidney health may change how body handles cancer drug
NCT ID NCT05469100
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 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.
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
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Orange County Research Center
Tustin, California, 92780, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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Riverside Clinical Research
Edgewater, Florida, 32132, United States
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Stanford Health Care, Valley Care Program
Pleasanton, California, 94588, United States
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