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

Loxo Oncology

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Selpercatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05089019

18177

J2G-MC-JZJZ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Selpercatinib (Test)

Experimental group

Description:

160 mg Selpercatinib (tablet formulation) given orally on days 1 and 15.

Treatment:

Drug: Selpercatinib

Selpercatinib (Reference)

Active Comparator group

Description:

160 mg Selpercatinib (2 X 80 mg capsule formulation) given orally on days 1 and 15.

Treatment:

Drug: Selpercatinib