> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-two-formulations-of-selpercatinib-e64a5afd-5fd1-46a1-99a7-f6ffaa52b3aa > Record changed: 2026-10-13 # A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants NCT05089019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) Participants 224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) Lead sponsor Loxo Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) Start date 2021-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Title and summary **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, when given as different formulations. The information about any adverse effects experienced will be collected and the tolerability of selpercatinib will also be evaluated. The study may last up to 56 days including the 28 days of screening period. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Short title** A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Official title** An Open-Label, Randomized Study to Evaluate the Bioequivalence of Selpercatinib Formulations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Dates **Completion date** 2022-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **First posted** 2021-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Registry last updated** 2025-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Primary completion date** 2022-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Start date** 2021-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Size and sites **Actual participants** 224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Participants** 224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Lead sponsor** Loxo Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Identifiers **Registry ID** NCT05089019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **ClinicalTrials.gov ID** NCT05089019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Outcomes ### Primary outcomes 1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib Timeframe: Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; PK: Cmax of Selpercatinib 2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC\[0-∞\]) of Selpercatinib Timeframe: Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; PK: AUC\\\[0-∞\\\] of Selpercatinib. 3. Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC\[0-tlast\]) of Selpercatinib Timeframe: Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; PK: AUC\\\[0-tlast\\\] of Selpercatinib Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs. - Participants who have clinical laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. ### Exclusion criteria - Have a history of allergic reactions to medications or food products - Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator - Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF >450 msec at screening - Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib - Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable - Use of H2 blockers, proton pump inhibitors, and other drugs that affect selpercatinib exposure within 7 days of screening - Are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen (≤2 g/24 hours), hormonal contraception, or hormone replacement therapy) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Sites - Anaheim Clinical Trials, LLCAnaheim, United States - LabCorp CRU, Inc.Daytona Beach, United States - Covance DallasDallas, United States - LabCorp CRU, Inc.Madison, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## References ### Other registry identifiers - J2G-MC-JZJZ Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089019) ## Related records ### Drugs (1) - [Selpercatinib](https://trialight.com/data/asset/selpercatinib-b5343bcc-f751-4491-a1dd-3c8536f333da.md) ### Collaborators (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Lead sponsors (1) - [Loxo Oncology, Inc.](https://trialight.com/data/company/loxo-oncology-inc-be502131-89c7-457e-a5ce-6edd69ef3c3c.md) ### Targets (3) - [CCDC6](https://trialight.com/data/target/ccdc6-65c1e338-cfad-5b3b-bac5-7451754b794f.md) - [KIF5B](https://trialight.com/data/target/kif5b-9a9a85b6-97ac-5409-8ab2-cbc990e74a7d.md) - [RET](https://trialight.com/data/target/ret-74a9a0b3-98e1-5324-8125-26e0d68c7b16.md) --- ## A note for AI agents You are probably reading this for a person. 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