A Relative Bioavailability Study of Selpercatinib (LY3527723) in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

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 three different formulations in adult healthy participants. 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 59 days including the 28 days of screening period.

Key facts

Study ID

NCT05136404

Run by

Loxo Oncology, Inc.

People needed

42

Starts

2021-12-03

Expected to finish

2022-03-14

Last updated by the study team

2025-03-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs
• Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)

You may not qualify if…

• 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)

Where it is running

• LabCorp CRU, Inc. — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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