A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Randomized Study to Evaluate the Bioequivalence of Selpercatinib Formulations

Conditions
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Healthy

Intervention / Treatment
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* Drug: Selpercatinib


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selpercatinib (Test)<br>Selpercatinib given orally on days 1 and 15. | Drug: Selpercatinib<br>* Administered orally<br>* Other names: LOXO-292;|
| Active Comparator: Selpercatinib (Reference)<br>Selpercatinib given orally on days 1 and 15. | Drug: Selpercatinib<br>* Administered orally<br>* Other names: LOXO-292;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib | Predose on Day 1 & 15 through Day 14 & 28 | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib | PK: AUC[0-∞] of Selpercatinib | Predose on Day 1 & 15 through Day 14 & 28 | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib | PK: AUC[0-tlast] of Selpercatinib | Predose on Day 1 & 15 through Day 14 & 28 |