HealthyPhase 1NCT05436912

A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants

A Phase 1 study testing Selpercatinib in people with Healthy and Hepatic Impairment, run by Eli Lilly and Company at 7 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 how selpercatinib gets into the blood stream and how long it takes the body to remove it when administered to participants with impaired hepatic function compared to healthy participants. Information about safety and tolerability will be collected. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Hepatic Impairment
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: 36 participants
Where: 7 sitesUnited States
Study dates: 10 Dec 2018to 30 Oct 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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after dose administration:
Male sterilization, with documented confirmation of surgical success. Male subjects will be surgically sterile for at least 90 days prior to Check-in (Day -1). If documentation is not available, male subjects must follow one of the contraception methods below:
Male condom with spermicide, or
For a female partner of male study participant:
Intrauterine device (IUD) (hormonal IUD; eg, Mirena®). Copper IUDs are acceptable (eg, ParaGard®);

Show all 10Show fewer

Established use of oral, implanted, transdermal, or hormonal method of contraception associated with inhibition of ovulation; or
Bilateral tubal ligation.
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 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

Who cannot join

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of treatment or early termination

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Orange County Research Institute
Anaheim, California, 92801
Riverside Clinical Research
Edgewater, Florida, 32132
Clinical Pharmacology of Miami
Miami, Florida, 33014
National Institute of Clinical Research
Monterey Park, California, 91754
Orlando Clinical Research Center
Orlando, Florida, 32809
The Texas Liver Institute
San Antonio, Texas, 78215
Orange County Research Center
Tustin, California, 92780

Other trials in United States

About this study

Official title: Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-292 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects

Conditions: Healthy, Hepatic Impairment
Being tested: Selpercatinib

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 NCT05436912
Study group	Role	What they receive
160 milligram (mg) Selpercatinib: Normal Hepatic Function	Experimental	160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1. Receives: Drug: Selpercatinib
160 mg Selpercatinib: Mild Hepatic Impairment	Experimental	160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh [CP] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1. Receives: Drug: Selpercatinib
160 mg Selpercatinib: Moderate Hepatic Impairment	Experimental	160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1. Receives: Drug: Selpercatinib
160 mg Selpercatinib: Severe Hepatic Impairment	Experimental	160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1. Receives: Drug: Selpercatinib

What is being measured

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib
PK: Cmax of selpercatinib was reported.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Time to Reach Cmax (Tmax) of Selpercatinib
PK: Tmax of Selpercatinib was reported.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Area Under the Concentration-time Curve (AUC), From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
PK: AUC0-t was calculated using the linear trapezoidal rule for increasing and decreasing concentrations.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: AUC Extrapolated to Infinity (AUC0-∞) of Selpercatinib
PK: Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-t) + Ct/λZ, where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Percentage Extrapolation for AUC (%AUCextrap) of Selpercatinib
PK: %AUCextrap of Selpercatinib was reported.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Apparent Terminal Elimination Rate Constant (λz) of Selpercatinib
PK: Apparent terminal elimination rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus-time profile during the terminal phase.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Apparent Terminal Elimination Half-life (t1/2) of Selpercatinib
PK: Apparent terminal elimination half-life (whenever possible), where t1/2 = natural log (ln)(2)/λZ.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Apparent Systemic Clearance (CL/F) of Selpercatinib
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Apparent Volume of Distribution During the Terminal Phase (Vd/F) of Selpercatinib
PK: Vd/F was calculated as CL/F/λZ.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Mean Residence Time (MRT) of Selpercatinib
PK: MRT represents the average time the drug (selpercatinib) stays in the body.
Measured: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Measured: Baseline up to Week 7

Timeline

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

10 Dec 201830 Oct 2019

First posted29 Jun 2022
Study start10 Dec 2018
Primary completion4 Oct 2019
Study completion30 Oct 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05436912
Sponsor's protocol ID: 17483
Other IDs: J2G-OX-JZJD, LOXO-RET-18022
Status last verified: Mar 2025
First submitted: 24 Jun 2022
Last updated: 13 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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-292 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects
ClinicalTrials.gov ID: NCT05436912
Acronym / sponsor ID: 17483
Conditions: Healthy, Hepatic Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 10 Dec 2018 (actual)
Primary completion: 4 Oct 2019 (actual)
Study completion: 30 Oct 2019 (actual)
First posted: 29 Jun 2022 (actual)
Results: Posted 13 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: 4

Arm	Type	Receives
160 milligram (mg) Selpercatinib: Normal Hepatic Function	Experimental	Drug: Selpercatinib160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
160 mg Selpercatinib: Mild Hepatic Impairment	Experimental	Drug: Selpercatinib160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh [CP] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
160 mg Selpercatinib: Moderate Hepatic Impairment	Experimental	Drug: Selpercatinib160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
160 mg Selpercatinib: Severe Hepatic Impairment	Experimental	Drug: Selpercatinib160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after dose administration:
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 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

Key exclusion criteria (5 listed)

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of treatment or early termination

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	160 mg Selpercatinib: Mild Hepatic Impairment, 160 mg Selpercatinib: Moderate Hepatic Impairment, 160 mg Selpercatinib: Severe Hepatic Impairment, 160 milligram (mg) Selpercatinib: Normal Hepatic Function

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Cmax of selpercatinib was reported.
PK: Time to Reach Cmax (Tmax) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Tmax of Selpercatinib was reported.
PK: Area Under the Concentration-time Curve (AUC), From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: AUC0-t was calculated using the linear trapezoidal rule for increasing and decreasing concentrations.
PK: AUC Extrapolated to Infinity (AUC0-∞) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-t) + Ct/λZ, where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant.
PK: Percentage Extrapolation for AUC (%AUCextrap) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: %AUCextrap of Selpercatinib was reported.
PK: Apparent Terminal Elimination Rate Constant (λz) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Apparent terminal elimination rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus-time profile during the terminal phase.
PK: Apparent Terminal Elimination Half-life (t1/2) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Apparent terminal elimination half-life (whenever possible), where t1/2 = natural log (ln)(2)/λZ.
PK: Apparent Systemic Clearance (CL/F) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).
PK: Apparent Volume of Distribution During the Terminal Phase (Vd/F) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: Vd/F was calculated as CL/F/λZ.
PK: Mean Residence Time (MRT) of Selpercatinib
Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
PK: MRT represents the average time the drug (selpercatinib) stays in the body.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Week 7
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

Results and safety

Results posted to the registry on 13 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
160 Milligram (mg) Selpercatinib: Normal Hepatic Function	12	12
160 mg Selpercatinib: Mild Hepatic Impairment	8	8
160 mg Selpercatinib: Moderate Hepatic Impairment	8	8
160 mg Selpercatinib: Severe Hepatic Impairment	8	8

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib

Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	160 mg Selpercatinib: Normal Hepatic Function n = 12	160 mg Selpercatinib: Mild Hepatic Impairment n = 8	160 mg Selpercatinib: Moderate Hepatic Impairment n = 8	160 mg Selpercatinib: Severe Hepatic Impairment n = 8
Value	898 (129.8)	1170 (78.0)	732 (185.6)	952 (72.3)

160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Mild Hepatic Impairment: Geometric Mean Ratio: 168.9 (90% CI 61.3 to 465.3), p = 0.3601, t-test, 2 sided
160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Moderate Hepatic Impairment: Geometric Mean Ratio: 92.2 (90% CI 23.0 to 368.9), p = 0.9146, t-test, 2 sided
160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Severe Hepatic Impairment: Geometric Mean Ratio: 119.6 (90% CI 43.4 to 329.3), p = 0.7478, t-test, 2 sided

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

Primary outcome: PK: Time to Reach Cmax (Tmax) of Selpercatinib

Time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose. Median (Full Range). Unit: hour

Measure	160 mg Selpercatinib: Normal Hepatic Function n = 12	160 mg Selpercatinib: Mild Hepatic Impairment n = 8	160 mg Selpercatinib: Moderate Hepatic Impairment n = 8	160 mg Selpercatinib: Severe Hepatic Impairment n = 8
Value	2.00 (1.00 to 24.00)	1.53 (1.00 to 2.03)	2.00 (1.00 to 24.42)	1.50 (1.00 to 3.00)

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

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

Measure	160 mg Selpercatinib: Normal Hepatic Function n = 12	160 mg Selpercatinib: Mild Hepatic Impairment n = 8	160 mg Selpercatinib: Moderate Hepatic Impairment n = 8	160 mg Selpercatinib: Severe Hepatic Impairment n = 8
Value	17700 (65.0)	20200 (43.1)	14600 (74.0)	27100 (33.7)

160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Mild Hepatic Impairment: Geometric Mean Ratio: 126.1 (90% CI 74.8 to 212.8), p = 0.4279, t-test, 2 sided
160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Moderate Hepatic Impairment: Geometric Mean Ratio: 92.4 (90% CI 46.4 to 183.9), p = 0.8341, t-test, 2 sided
160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Severe Hepatic Impairment: Geometric Mean Ratio: 169.1 (90% CI 97.1 to 294.6), p = 0.1159, t-test, 2 sided

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

Primary outcome: PK: AUC Extrapolated to Infinity (AUC0-∞) of Selpercatinib

Measure	160 mg Selpercatinib: Normal Hepatic Function n = 12	160 mg Selpercatinib: Mild Hepatic Impairment n = 8	160 mg Selpercatinib: Moderate Hepatic Impairment n = 8	Participants With Severe Hepatic Impairment n = 8
Value	17700 (64.9)	20200 (43.0)	14700 (73.6)	27300 (33.5)

160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Mild Hepatic Impairment: Geometric Mean Ratio: 126.0 (90% CI 74.8 to 212.4), p = 0.4289, t-test, 2 sided
160 mg Selpercatinib: Normal Hepatic Function vs 160 mg Selpercatinib: Moderate Hepatic Impairment: Geometric Mean Ratio: 92.3 (90% CI 46.5 to 183.3), p = 0.8322, t-test, 2 sided
160 mg Selpercatinib: Normal Hepatic Function vs Participants With Severe Hepatic Impairment: Geometric Mean Ratio: 169.6 (90% CI 97.6 to 294.6), p = 0.1131, t-test, 2 sided

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

Adverse events

Time frame: Baseline up to Week 7. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
160 mg Selpercatinib: Normal Hepatic Function	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
160 mg Selpercatinib: Mild Hepatic Impairment	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
160 mg Selpercatinib: Moderate Hepatic Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8
160 mg Selpercatinib: Severe Hepatic Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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

7 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 Hepatic Impairment, run by Eli Lilly and Company at 7 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 10 inclusion and 5 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 13 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 7 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 13 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): Maximum Concentration (Cmax) of Selpercatinib (time frame: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose). The study lists 11 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 NCT05436912.

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 13 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.