HealthyPhase 1NCT05469100

A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function

A Phase 1 study testing Selpercatinib in people with Healthy and Renal Insufficiency, run by Eli Lilly and Company at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 9 days, excluding screening. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Renal Insufficiency
What is being tested?: Selpercatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 6 sitesUnited States
Study dates: 19 Dec 2018to 7 Aug 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

Show all 14Show fewer

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Anaheim Regional Center
Anaheim, California, 92801
Riverside Clinical Research
Edgewater, Florida, 32132
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
Stanford Health Care, Valley Care Program
Pleasanton, California, 94588
Orange County Research Center
Tustin, California, 92780

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of LOXO-292

Conditions: Healthy, Renal Insufficiency
Being tested: Selpercatinib
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelpercatinibDrug
Also called LY3527723, LOXO-292
Administered orally

Study groups in NCT05469100
Study group	Role	What they receive
Selpercatinib (Control; Normal Renal Function)	Experimental	Participants with normal renal function (estimated glomerular filtration rate greater than or equal to [eGFR ≥ 90 milliliters per minute (mL/min) per 1.73 square meters (m²)] received a single 160 milligrams (mg) oral dose of Selpercatinib on Day 1, administered in a fasted state. Receives: Drug: Selpercatinib
Selpercatinib (Mild Renal Impairment)	Experimental	Participants with mild renal impairment (eGFR between 60 and 90 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state. Receives: Drug: Selpercatinib
Selpercatinib (Moderate Renal Impairment)	Experimental	Participants with moderate renal impairment (eGFR between 30 and 60 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state. Receives: Drug: Selpercatinib
Selpercatinib (Severe Renal Impairment)	Experimental	Participants with severe renal impairment (eGFR less than (<) 30 mL/min/1.73 m² and not requiring hemodialysis) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state. Receives: Drug: Selpercatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma
PK: AUC0-t of Selpercatinib
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib in Plasma
PK: AUC0-inf of Selpercatinib
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib.in Plasma
PK: Percentage of AUC0-inf extrapolated was calculated as (1 - AUC0-t/AUC0-inf) * 100.
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Maximum Observed Concentration (Cmax) of Selpercatinib in Plasma
PK: Cmax of Selpercatinib
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Selpercatinib in Plasma
PK: Tmax of Selpercatinib
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib in Plasma
PK: Apparent terminal elimination rate constant; represents the fraction of drug eliminated per unit time calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations).
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib in Plasma
PK: t½ of Selpercatinib.
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib in Plasma
PK: CL/F of Selpercatinib
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Selpercatinib in Plasma
PK: Vz/F of Selpercatinib
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Unbound AUC0-t (AUC0-t,u) of Selpercatinib in Plasma
AUC0-t,u was calculated by multiplying AUC0-t by Fu (i.e., AUC0-t*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Unbound AUC0-inf (AUC0-inf,u) of Selpercatinib in Plasma
AUC0-inf,u was calculated by multiplying AUC0-inf by Fu (i.e., AUC0-inf*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Unbound Cmax (Cmax,u) of Selpercatinib in Plasma
Cmax,u was calculated by multiplying Cmax by Fu (i.e., Cmax*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Unbound CL/F (CL/F,u) of Selpercatinib in Plasma
CL/F,u was calculated by multiplying CL/F by Fu (i.e., CL/F*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Unbound Vz/F (Vz/F,u) of Selpercatinib in Plasma
Vz/F,u was calculated by multiplying Vz/F by Fu (i.e., Vz/F*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
Measured: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cumulative Amount of Selpercatinib Excreted (CumAe) in Urine
PK: CumAe was reported. The urine sampling time points from pre-dose through 168 hours post-dose were used to assess this outcome.
Measured: Predose (spot collection), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours postdose
PK: Cumulative Percentage of Administered Selpercatinib Dose (Cum%Dose) Excreted in Urine
PK: Cum%Dose was reported. The urine sampling time points from pre-dose through 168 hours post-dose were used to assess this outcome.
Measured: Predose (spot collection), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours postdose
PK: Renal Clearance (CLr) of Selpercatinib in Urine
PK: CLr of Selpercatinib was reported.The urine sampling time points from pre-dose through 168 hours post-dose were used to assess this outcome.
Measured: Predose (spot collection), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 20187 Aug 2019

First posted21 Jul 2022
Study start19 Dec 2018
Primary completion7 Aug 2019
Study completion7 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05469100
Sponsor's protocol ID: 17484
Other IDs: J2G-OX-JZJE, LOXO-RET-18023
Status last verified: Aug 2025
First submitted: 20 Jul 2022
Last updated: 18 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of LOXO-292
ClinicalTrials.gov ID: NCT05469100
Acronym / sponsor ID: 17484
Conditions: Healthy, Renal Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 19 Dec 2018 (actual)
Primary completion: 7 Aug 2019 (actual)
Study completion: 7 Aug 2019 (actual)
First posted: 21 Jul 2022 (actual)
Results: Posted 18 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Selpercatinib (Control; Normal Renal Function)	Experimental	Drug: SelpercatinibParticipants with normal renal function (estimated glomerular filtration rate greater than or equal to [eGFR ≥ 90 milliliters per minute (mL/min) per 1.73 square meters (m²)] received a single 160 milligrams (mg) oral dose of Selpercatinib on Day 1, administered in a fasted state.
Selpercatinib (Mild Renal Impairment)	Experimental	Drug: SelpercatinibParticipants with mild renal impairment (eGFR between 60 and 90 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.
Selpercatinib (Moderate Renal Impairment)	Experimental	Drug: SelpercatinibParticipants with moderate renal impairment (eGFR between 30 and 60 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.
Selpercatinib (Severe Renal Impairment)	Experimental	Drug: SelpercatinibParticipants with severe renal impairment (eGFR less than (<) 30 mL/min/1.73 m² and not requiring hemodialysis) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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
Participant has stable renal disease status and function at least 1 month prior to LOXO-292 administration.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelpercatinibAlso: LY3527723, LOXO-292Administered orally	Drug	Selpercatinib (Control; Normal Renal Function), Selpercatinib (Mild Renal Impairment), Selpercatinib (Moderate Renal Impairment), Selpercatinib (Severe Renal Impairment)

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-t of Selpercatinib
PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of Selpercatinib
PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib.in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Percentage of AUC0-inf extrapolated was calculated as (1 - AUC0-t/AUC0-inf) * 100.
PK: Maximum Observed Concentration (Cmax) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of Selpercatinib
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of Selpercatinib
PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent terminal elimination rate constant; represents the fraction of drug eliminated per unit time calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations).
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of Selpercatinib.
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: CL/F of Selpercatinib
PK: Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Vz/F of Selpercatinib
PK: Unbound AUC0-t (AUC0-t,u) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
AUC0-t,u was calculated by multiplying AUC0-t by Fu (i.e., AUC0-t*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
PK: Unbound AUC0-inf (AUC0-inf,u) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
AUC0-inf,u was calculated by multiplying AUC0-inf by Fu (i.e., AUC0-inf*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
PK: Unbound Cmax (Cmax,u) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
Cmax,u was calculated by multiplying Cmax by Fu (i.e., Cmax*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
PK: Unbound CL/F (CL/F,u) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
CL/F,u was calculated by multiplying CL/F by Fu (i.e., CL/F*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
PK: Unbound Vz/F (Vz/F,u) of Selpercatinib in Plasma
Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
Vz/F,u was calculated by multiplying Vz/F by Fu (i.e., Vz/F*Fu). Fu represented the unbound fraction of Selpercatinib in plasma, that is, the portion of the drug not bound to plasma proteins.
PK: Cumulative Amount of Selpercatinib Excreted (CumAe) in Urine
Time frame: Predose (spot collection), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours postdose
PK: CumAe was reported. The urine sampling time points from pre-dose through 168 hours post-dose were used to assess this outcome.
PK: Cumulative Percentage of Administered Selpercatinib Dose (Cum%Dose) Excreted in Urine
Time frame: Predose (spot collection), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours postdose
PK: Cum%Dose was reported. The urine sampling time points from pre-dose through 168 hours post-dose were used to assess this outcome.
PK: Renal Clearance (CLr) of Selpercatinib in Urine
Time frame: Predose (spot collection), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours postdose
PK: CLr of Selpercatinib was reported.The urine sampling time points from pre-dose through 168 hours post-dose were used to assess this outcome.

Results and safety

Results posted to the registry on 18 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selpercatinib (Control; Normal Renal Function)	13	13
Selpercatinib (Mild Renal Impairment)	9	9
Selpercatinib (Moderate Renal Impairment)	8	8
Selpercatinib (Severe Renal Impairment)	7	7

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma

Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Selpercatinib (Control; Normal Renal Function) n = 10	Selpercatinib (Mild Renal Impairment) n = 8	Selpercatinib (Moderate Renal Impairment) n = 8	Selpercatinib (Severe Renal Impairment) n = 7
Value	19770 (52.1)	23440 (36.0)	29270 (25.6)	20640 (71.0)

Population analysed: All enrolled participants who received at least one dose of the study drug and had evaluable PK data. Participants were excluded from the analysis if they experienced emesis (vomiting) that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Primary outcome: PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib in Plasma

Measure	Selpercatinib (Control; Normal Renal Function) n = 10	Selpercatinib (Mild Renal Impairment) n = 8	Selpercatinib (Moderate Renal Impairment) n = 8	Selpercatinib (Severe Renal Impairment) n = 7
Value	19870 (52.0)	23510 (36.0)	29470 (25.8)	21000 (71.4)

Primary outcome: PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib.in Plasma

Time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose. Mean (Standard Deviation). Unit: percentage of AUCextrap

Measure	Selpercatinib (Control; Normal Renal Function) n = 10	Selpercatinib (Mild Renal Impairment) n = 8	Selpercatinib (Moderate Renal Impairment) n = 8	Selpercatinib (Severe Renal Impairment) n = 7
Value	0.4856 (0.12819)	0.2988 (0.10713)	0.6738 (0.33398)	1.706 (1.5917)

Primary outcome: PK: Maximum Observed Concentration (Cmax) of Selpercatinib in Plasma

Measure	Selpercatinib (Control; Normal Renal Function) n = 10	Selpercatinib (Mild Renal Impairment) n = 8	Selpercatinib (Moderate Renal Impairment) n = 8	Selpercatinib (Severe Renal Impairment) n = 7
Value	1399 (107.3)	2247 (22.3)	1742 (25.1)	1006 (159.6)

Adverse events

Time frame: Baseline up to 15 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Selpercatinib (Control; Normal Renal Function)	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13
Selpercatinib (Mild Renal Impairment)	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Selpercatinib (Moderate Renal Impairment)	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Selpercatinib (Severe Renal Impairment)	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selpercatinib in people with Healthy and Renal Insufficiency, run by Eli Lilly and Company at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma (time frame: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.