HealthyPhase 1NCT05630287

A Study of Absorption, Metabolism, Excretion, and Absolute Bioavailability of Carbon-14-Labelled [14C] Selpercatinib (LY3527723) in Healthy Male Participants

A Phase 1 study testing [14C]-Selpercatinib and Selpercatinib in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it and also to assess the pharmacokinetics (PK), metabolism, and routes and extent of elimination of selpercatinib in healthy male participants. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: [14C]-Selpercatinib and Selpercatinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2018to 24 Sep 2018
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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²)
Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
Participants will be surgically sterile for at least 90 days prior to Check in or, when sexually active with female partners of childbearing potential, will agree to use effective contraception methods or abstain from sexual intercourse from the time of first dose through 90 days after study drug administration

Who cannot join

Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
Use or intention to use any medications/products known strong inducers or inhibitors of Cytochrome P450 3A4 enzymes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)

Trial locations and contacts

1 site in 1 country.

United States1 site

LabCorp CRU, Inc.
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Two-part Study to Investigate the Absorption, Metabolism, and Excretion, and the Absolute Bioavailability of [14C]-LOXO-292 in Healthy Male Subjects

Conditions: Healthy
Being tested: [14C]-Selpercatinib, Selpercatinib

What participants receive

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

[14C]-SelpercatinibDrug
Also called LY3527723, LOXO-292
Administered as an oral solution
SelpercatinibDrug
Also called LY3527723, LOXO-292
Administered orally
[14C]-SelpercatinibDrug
Also called LY3527723, LOXO-292
Administered intravenously

Study groups in NCT05630287
Study group	Role	What they receive
Carbon-14-labelled [14C]-Selpercatinib - Part 1	Experimental	Participants received a single oral dose of 165 milligram (mg) of [14C]-Selpercatinib (containing approximately 40 µCi). Receives: Drug: [14C]-Selpercatinib
Selpercatinib and [14C]-Selpercatinib - Part 2	Experimental	Participants received a single oral dose of 160 mg Selpercatinib followed by single dose of <100 µg of [14C]-Selpercatinib (containing approximately 1 µCi) administered intravenously (IV). Receives: Drug: Selpercatinib; Drug: [14C]-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 Time of the Last Quantifiable Concentration (AUClast) of Selpercatinib in Plasma (Part 1)
PK: AUClast of Selpercatinib in plasma
Measured: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUClast of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
PK: AUClast of [14C] Selpercatinib in plasma and whole blood
Measured: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 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 (Part 1)
PK: AUC0-inf of Selpercatinib in plasma
Measured: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
PK: AUC0-inf of [14C] Selpercatinib in plasma and whole blood
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Area Under the Concentration-time Curve, From Time 0 to Hour 24 (AUC0-24) of Selpercatinib in Plasma (Part 1)
PK: AUC0-24 of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
PK: (AUC0-24) of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
PK: AUC0-24 of [14C] Selpercatinib in plasma and whole blood
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
PK: Maximum Observed Concentration (Cmax) of Selpercatinib in Plasma (Part 1)
PK: Cmax of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
PK: Cmax of [14C] Selpercatinib in plasma and whole blood
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Time to Reach Cmax (Tmax) of Selpercatinib in Plasma (Part 1)
PK: Tmax of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
PK: Tmax of [14C] Selpercatinib in plasma and whole blood
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib in Plasma (Part 1)
PK: t½ of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
PK: t½ of [14C] Selpercatinib in plasma and whole blood
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Systemic Clearance (CL/F) of Selpercatinibin Plasma (Part 1)
PK: CL/F of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Selpercatinib in Plasma (Part 1)
PK: Vz/F of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Plasma Selpercatinib/Total Radioactivity AUC0-24 Ratio (Part 1)
PK: AUC0-24 of Selpercatinib in plasma/AUC0-24 of total radioactivity in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose
PK: Blood/Plasma Total Radioactivity AUC0-24 Ratio (Part 1)
PK: AUC0-24 of total radioactivity in whole blood/AUC0-24 of total radioactivity in whole blood
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
PK: AUClast of Selpercatinib in Plasma (Part 2)
PK: AUClast of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUClast of [14C] Selpercatinib in Plasma (Part 2)
PK: AUClast of [14C] Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of Selpercatinib in Plasma (Part 2)
PK: AUC0-inf of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of [14C] Selpercatinib in Plasma (Part 2)
PK: AUC0-inf of [14C] Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of Selpercatinib in Plasma (Part 2)
PK: Cmax of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of [14C] Selpercatinib in Plasma (Part 2)
PK: Cmax of [14C] Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of Selpercatinib in Plasma (Part 2)
PK: Tmax of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of [14C] Selpercatinib in Plasma (Part 2)
PK: Tmax of [14C] Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of Selpercatinib in Plasma (Part 2)
PK: t½ of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of [14C] Selpercatinib in Plasma (Part 2)
PK: t½ of [14C] Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: CL/F of Selpercatinib in Plasma (Part 2)
PK: CL/F of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Systemic Clearance (CL) of [14C] Selpercatinib in Plasma (Part 2)
PK: CL of [14C] Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Vz/F of Selpercatinib in Plasma (Part 2)
PK: Vz/F of Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Volume of Distribution During the Terminal Phase (Vz) of [14C] Selpercatinib in Plasma (Part 2)
PK: Vz of [14C] Selpercatinib in plasma
Measured: Pre-dose up to 168 hour post-dose
PK: Volume of Distribution at Steady State (Vss) of [14C] Selpercatinib in Plasma (Part 2)
PK: Vss of [14C] Selpercatinib in plasma
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Absolute Bioavailability (F) of Selpercatinib in Plasma (Part 2)
Absolute bioavailability was determined by comparing the plasma exposure of LOXO-292 following oral dosing with the plasma exposure of [14C]-LOXO-292 following IV dosing.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

Timeline

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

1 Aug 201824 Sep 2018

First posted29 Nov 2022
Study start1 Aug 2018
Primary completion24 Sep 2018
Study completion24 Sep 2018

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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05630287
Sponsor's protocol ID: 17768
Other IDs: J2G-OX-JZJT, LOXO-RET-18016
Status last verified: Apr 2025
First submitted: 21 Nov 2022
Last updated: 23 Apr 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?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Two-part Study to Investigate the Absorption, Metabolism, and Excretion, and the Absolute Bioavailability of [14C]-LOXO-292 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT05630287
Acronym / sponsor ID: 17768
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 1 Aug 2018 (actual)
Primary completion: 24 Sep 2018 (actual)
Study completion: 24 Sep 2018 (actual)
First posted: 29 Nov 2022 (actual)
Results: Posted 23 Apr 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: 2

Arm	Type	Receives
Carbon-14-labelled [14C]-Selpercatinib - Part 1	Experimental	Drug: [14C]-SelpercatinibParticipants received a single oral dose of 165 milligram (mg) of [14C]-Selpercatinib (containing approximately 40 µCi).
Selpercatinib and [14C]-Selpercatinib - Part 2	Experimental	Drug: Selpercatinib, Drug: [14C]-SelpercatinibParticipants received a single oral dose of 160 mg Selpercatinib followed by single dose of <100 µg of [14C]-Selpercatinib (containing approximately 1 µCi) administered intravenously (IV).

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²)
Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
Participants will be surgically sterile for at least 90 days prior to Check in or, when sexually active with female partners of childbearing potential, will agree to use effective contraception methods or abstain from sexual intercourse from the time of first dose through 90 days after study drug administration

Key exclusion criteria (3 listed)

Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
Use or intention to use any medications/products known strong inducers or inhibitors of Cytochrome P450 3A4 enzymes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)

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
[14C]-SelpercatinibAlso: LY3527723, LOXO-292Administered as an oral solution	Drug	Carbon-14-labelled [14C]-Selpercatinib - Part 1
SelpercatinibAlso: LY3527723, LOXO-292Administered orally	Drug	Selpercatinib and [14C]-Selpercatinib - Part 2
[14C]-SelpercatinibAlso: LY3527723, LOXO-292Administered intravenously	Drug	Selpercatinib and [14C]-Selpercatinib - Part 2

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Selpercatinib in Plasma (Part 1)
Time frame: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUClast of Selpercatinib in plasma
PK: AUClast of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
Time frame: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUClast of [14C] Selpercatinib in plasma and whole blood
PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib in Plasma (Part 1)
Time frame: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of Selpercatinib in plasma
PK: AUC0-inf of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of [14C] Selpercatinib in plasma and whole blood
PK: Area Under the Concentration-time Curve, From Time 0 to Hour 24 (AUC0-24) of Selpercatinib in Plasma (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
PK: AUC0-24 of Selpercatinib in plasma
PK: (AUC0-24) of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
PK: AUC0-24 of [14C] Selpercatinib in plasma and whole blood
PK: Maximum Observed Concentration (Cmax) of Selpercatinib in Plasma (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of Selpercatinib in plasma
PK: Cmax of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of [14C] Selpercatinib in plasma and whole blood
PK: Time to Reach Cmax (Tmax) of Selpercatinib in Plasma (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of Selpercatinib in plasma
PK: Tmax of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of [14C] Selpercatinib in plasma and whole blood
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib in Plasma (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of Selpercatinib in plasma
PK: t½ of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of [14C] Selpercatinib in plasma and whole blood
PK: Apparent Systemic Clearance (CL/F) of Selpercatinibin Plasma (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: CL/F of Selpercatinib in plasma
PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Selpercatinib in Plasma (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Vz/F of Selpercatinib in plasma
PK: Plasma Selpercatinib/Total Radioactivity AUC0-24 Ratio (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose
PK: AUC0-24 of Selpercatinib in plasma/AUC0-24 of total radioactivity in plasma
PK: Blood/Plasma Total Radioactivity AUC0-24 Ratio (Part 1)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
PK: AUC0-24 of total radioactivity in whole blood/AUC0-24 of total radioactivity in whole blood
PK: AUClast of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUClast of Selpercatinib in plasma
PK: AUClast of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUClast of [14C] Selpercatinib in plasma
PK: AUC0-inf of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of Selpercatinib in plasma
PK: AUC0-inf of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of [14C] Selpercatinib in plasma
PK: Cmax of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of Selpercatinib in plasma
PK: Cmax of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of [14C] Selpercatinib in plasma
PK: Tmax of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of Selpercatinib in plasma
PK: Tmax of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of [14C] Selpercatinib in plasma
PK: t½ of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of Selpercatinib in plasma
PK: t½ of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t½ of [14C] Selpercatinib in plasma
PK: CL/F of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: CL/F of Selpercatinib in plasma
PK: Systemic Clearance (CL) of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: CL of [14C] Selpercatinib in plasma
PK: Vz/F of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Vz/F of Selpercatinib in plasma
PK: Volume of Distribution During the Terminal Phase (Vz) of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Pre-dose up to 168 hour post-dose
PK: Vz of [14C] Selpercatinib in plasma
PK: Volume of Distribution at Steady State (Vss) of [14C] Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Vss of [14C] Selpercatinib in plasma
PK: Absolute Bioavailability (F) of Selpercatinib in Plasma (Part 2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
Absolute bioavailability was determined by comparing the plasma exposure of LOXO-292 following oral dosing with the plasma exposure of [14C]-LOXO-292 following IV dosing.

Results and safety

Results posted to the registry on 23 Apr 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
Carbon-14-labelled [14C]-Selpercatinib - Part 1	6	6
Selpercatinib and [14C]-Selpercatinib - Part 2	6	6

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Selpercatinib in Plasma (Part 1)

Time frame: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	[14C]-Selpercatinib - Part 1 n = 6
Value	24100 (20.2)

Population analysed: All participants who received at least 1 dose of study drug and had evaluable PK data.

Primary outcome: PK: AUClast of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity

Time frame: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng equivalents per gram (h*ng Eq/g)

Measure	[14C]-Selpercatinib - Part 1 n = 6
Plasma	21400 (21.9)
Whole Blood	11400 (38.2)

Population analysed: All participants who received at least 1 dose of study drug and had evaluable PK data.

Primary outcome: PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib in Plasma (Part 1)

Time frame: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*nanogram per milliliter (h*ng/mL)

Measure	[14C]-Selpercatinib - Part 1 n = 6
Value	24200 (20.2)

Population analysed: All participants who received at least 1 dose of study drug and had evaluable PK data.

Primary outcome: PK: AUC0-inf of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng Eq/g

Measure	[14C]-Selpercatinib - Part 1 n = 6
Plasma	26900 (25.8)
Whole Blood	16700 (32.8)

Population analysed: All participants who received at least 1 dose of study drug and had evaluable PK data.

Adverse events

Time frame: Part 1: Baseline up to Day 29; Part 2: Baseline up to Day 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carbon-14-labelled [14C]-Selpercatinib	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Selpercatinib and [14C]-Selpercatinib	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-Selpercatinib and Selpercatinib in people with Healthy, run by Eli Lilly and Company at 1 site 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 3 inclusion and 3 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 23 Apr 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 Time of the Last Quantifiable Concentration (AUClast) of Selpercatinib in Plasma (Part 1) (time frame: PK: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose). The study lists 32 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 NCT05630287.

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 23 Apr 2025.