CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
[14C]-Selpercatinib +2 moredrug
Likely dose
Selpercatinib administered orally; [14C]-selpercatinib as oral solution or intravenouslyAI-extracted
Key inclusion· 2
  • ✓Body mass index (BMI) between 18.0 and 32.0 kg/m²
  • ✓Normal blood pressure, pulse rate, ECG, and blood/urine laboratory results acceptable for study participation
Key exclusion· 3
  • ✕Participation in any radiolabeled investigational drug trial within 12 months prior to check-in
  • ✕Exposure to significant radiation (e.g. serial x-ray, CT scans, barium meal, or occupational radiation exposure) within 12 months prior to check-in
  • ✕Use of strong CYP3A4 enzyme inducers or inhibitors (including St. John's wort) within 30 days prior to check-in, unless investigator deems acceptable

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05630287
NCT05630287Phase 1Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Nov 29, 2022·Updated Apr 23, 2025

In Brief

A Phase 1 clinical trial evaluating [14C]-Selpercatinib and Selpercatinib for Healthy. Completed, enrolled 12 participants across 1 site.

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsLoxo Oncology, Inc.

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 29, 2022
Enrollment StartAug 1, 2018
Primary CompletionSep 24, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.6 years ago

Interventions

[14C]-Selpercatinibdrug

Administered as an oral solution

Selpercatinibdrug

Administered orally

[14C]-Selpercatinibdrug

Administered intravenously