NCT05436912 is a Phase 1 clinical trial of Selpercatinib in Healthy, sponsored by Eli Lilly and Company.

Who is sponsoring NCT05436912?

NCT05436912 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT05436912?

Interventions in NCT05436912: Selpercatinib.

What condition does NCT05436912 study?

NCT05436912 studies Healthy, Hepatic Impairment.

Is NCT05436912 still recruiting?

NCT05436912 is currently completed. Last updated 13 April 2025.

Are results published for NCT05436912?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-04-13 · How we verify

NCT05436912

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 13 April 2025

What this trial tests

Phase 1 trial testing Selpercatinib in Healthy in 36 participants. Completed in 30 October 2019.

Timeline

10 December 2018

Primary endpoint
4 October 2019

30 October 2019

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	36
Start date	10 December 2018
Primary completion	4 October 2019
Estimated completion	30 October 2019
Sites	7 locations across United States

Drugs / interventions tested

Selpercatinib (SELPERCATINIB) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →
Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy or Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib Primary · 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.

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	898	± 129.8
160 mg Selpercatinib: Mild Hepatic Impairment	1170	± 78.0
160 mg Selpercatinib: Moderate Hepatic Impairment	732	± 185.6
160 mg Selpercatinib: Severe Hepatic Impairment	952	± 72.3

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

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	2.00	1.00 – 24.00
160 mg Selpercatinib: Mild Hepatic Impairment	1.53	1.00 – 2.03
160 mg Selpercatinib: Moderate Hepatic Impairment	2.00	1.00 – 24.42
160 mg Selpercatinib: Severe Hepatic Impairment	1.50	1.00 – 3.00

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

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	17700	± 65.0
160 mg Selpercatinib: Mild Hepatic Impairment	20200	± 43.1
160 mg Selpercatinib: Moderate Hepatic Impairment	14600	± 74.0
160 mg Selpercatinib: Severe Hepatic Impairment	27100	± 33.7

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

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	17700	± 64.9
160 mg Selpercatinib: Mild Hepatic Impairment	20200	± 43.0
160 mg Selpercatinib: Moderate Hepatic Impairment	14700	± 73.6
Participants With Severe Hepatic Impairment	27300	± 33.5

PK: Percentage Extrapolation for AUC (%AUCextrap) of Selpercatinib Primary · 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.

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	0.422	± 0.190
160 mg Selpercatinib: Mild Hepatic Impairment	0.310	± 0.197
160 mg Selpercatinib: Moderate Hepatic Impairment	0.373	± 0.328
160 mg Selpercatinib: Severe Hepatic Impairment	0.685	± 0.379

PK: Apparent Terminal Elimination Rate Constant (λz) of Selpercatinib Primary · 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.

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	0.0220	± 61.4
160 mg Selpercatinib: Mild Hepatic Impairment	0.0266	± 39.8
160 mg Selpercatinib: Moderate Hepatic Impairment	0.0320	± 29.0
160 mg Selpercatinib: Severe Hepatic Impairment	0.0175	± 28.8

PK: Apparent Terminal Elimination Half-life (t1/2) of Selpercatinib Primary · 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.

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	36.4	± 19.9
160 mg Selpercatinib: Mild Hepatic Impairment	27.9	± 12.2
160 mg Selpercatinib: Moderate Hepatic Impairment	22.4	± 6.30
160 mg Selpercatinib: Severe Hepatic Impairment	41.3	± 13.5

PK: Apparent Systemic Clearance (CL/F) of Selpercatinib Primary · 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).

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	9.03	± 64.9
160 mg Selpercatinib: Mild Hepatic Impairment	7.90	± 43.0
160 mg Selpercatinib: Moderate Hepatic Impairment	10.9	± 73.6
160 mg Selpercatinib: Severe Hepatic Impairment	5.87	± 33.5

PK: Apparent Volume of Distribution During the Terminal Phase (Vd/F) of Selpercatinib Primary · 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.

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	411	± 51.5
160 mg Selpercatinib: Mild Hepatic Impairment	297	± 58.0
160 mg Selpercatinib: Moderate Hepatic Impairment	340	± 68.6
160 mg Selpercatinib: Severe Hepatic Impairment	336	± 51.8

PK: Mean Residence Time (MRT) of Selpercatinib Primary · 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.

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	25.5	± 21.9
160 mg Selpercatinib: Mild Hepatic Impairment	23.3	± 28.9
160 mg Selpercatinib: Moderate Hepatic Impairment	24.2	± 39.2
160 mg Selpercatinib: Severe Hepatic Impairment	34.3	± 20.2

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Primary · 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.

Group	Value	95% CI
160 mg Selpercatinib: Normal Hepatic Function	0
160 mg Selpercatinib: Mild Hepatic Impairment	0
160 mg Selpercatinib: Moderate Hepatic Impairment	0
160 mg Selpercatinib: Severe Hepatic Impairment	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Week 7. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

160 mg Selpercatinib: Normal Hepatic Function

Serious: 0/12 (0%)

Deaths: 0/12

160 mg Selpercatinib: Mild Hepatic Impairment

Serious: 0/8 (0%)

Deaths: 0/8

160 mg Selpercatinib: Moderate Hepatic Impairment

Serious: 0/8 (0%)

Deaths: 0/8

160 mg Selpercatinib: Severe Hepatic Impairment

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (8 terms — click to expand)

Reaction	System	160 mg Selpercatinib: Norm…	160 mg Selpercatinib: Mild…	160 mg Selpercatinib: Mode…	160 mg Selpercatinib: Seve…
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT05436912 adverse events section.

Sponsor's own description

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. The study will last up to about 7 weeks, inclusive of screening period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Eli Lilly and Company trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05436912 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 13 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05436912.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05436912

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Selpercatinib

Other recruiting trials for Healthy

Other Eli Lilly and Company trials

Verify against primary sources