NCT05630287 is a Phase 1 clinical trial of [14C]-Selpercatinib in Healthy, sponsored by Eli Lilly and Company.

Who is sponsoring NCT05630287?

NCT05630287 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT05630287?

Interventions in NCT05630287: [14C]-Selpercatinib, Selpercatinib, [14C]-Selpercatinib.

Is NCT05630287 still recruiting?

NCT05630287 is currently completed. Last updated 23 April 2025.

Are results published for NCT05630287?

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

Last reviewed 2025-04-23 · How we verify

NCT05630287

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

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

Completed Phase 1 Results posted Last updated 23 April 2025

What this trial tests

Phase 1 trial testing [14C]-Selpercatinib in Healthy in 12 participants. Completed in 24 September 2018.

Timeline

1 August 2018

Primary endpoint
24 September 2018

24 September 2018

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	12
Start date	1 August 2018
Primary completion	24 September 2018
Estimated completion	24 September 2018
Sites	1 location across United States

Drugs / interventions tested

[14C]-Selpercatinib — full drug profile →
Selpercatinib (SELPERCATINIB) — full drug profile →
[14C]-Selpercatinib — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy. 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): Area Under the Concentration-time Curve, From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Selpercatinib in Plasma (Part 1) Primary · 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

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	24100	± 20.2

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

Plasma

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	21400	± 21.9

Whole Blood

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	11400	± 38.2

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

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	24200	± 20.2

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

Plasma

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	26900	± 25.8

Whole Blood

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	16700	± 32.8

PK: Area Under the Concentration-time Curve, From Time 0 to Hour 24 (AUC0-24) of Selpercatinib in Plasma (Part 1) Primary · 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

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	17100	± 17.7

PK: (AUC0-24) of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity Primary · 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

Plasma

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	21400	± 21.9

Whole Blood

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	12600	± 23.4

PK: Maximum Observed Concentration (Cmax) of Selpercatinib in Plasma (Part 1) Primary · 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

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	1890	± 22.7

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

Plasma

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	2240	± 24.6

Whole Blood

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	1260	± 25.8

PK: Time to Reach Cmax (Tmax) of Selpercatinib in Plasma (Part 1) Primary · 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

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	1.25	1.00 – 1.50

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

Plasma

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	1.50	1.00 – 1.50

Whole Blood

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	1.50	1.00 – 2.00

PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib in Plasma (Part 1) Primary · 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

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	36.5	± 18.0

PK: t½ of [14C] Selpercatinib in Plasma and Whole Blood (Part 1) for Total Radioactivity Primary · 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

Plasma

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	12.2	± 2.36

Whole Blood

Group	Value	95% CI
[14C]-Selpercatinib - Part 1	10.5	± 2.79

Adverse events — posted to ClinicalTrials.gov

Time frame: Part 1: Baseline up to Day 29; Part 2: Baseline up to Day 16. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Carbon-14-labelled [14C]-Selpercatinib

Serious: 0/6 (0%)

Deaths: 0/6

Selpercatinib and [14C]-Selpercatinib

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (7 terms — click to expand)

Reaction	System	Carbon-14-labelled [14C]-S…	Selpercatinib and [14C]-Se…
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Hot flush	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT05630287 adverse events section.

Sponsor's own description

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. The study will last up to 59 days (Part 1) or 46 days (Part 2) including screening and 7-day safety follow-up.

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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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 NCT05630287 (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: 23 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/NCT05630287.

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

NCT05630287

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 recruiting trials for Healthy

Other Eli Lilly and Company trials

Verify against primary sources