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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089019
• Other study ID #: 18177
• Secondary ID: J2G-MC-JZJZ
• Status: Completed
• Phase: Phase 1
• Start date: October 29, 2021
• Est. completion date: July 19, 2022

Study information

• Verified date: August 1, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Selpercatinib
Administered orally

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Covance Dallas	Dallas	Texas
United States	LabCorp CRU, Inc.	Daytona Beach	Florida
United States	LabCorp CRU, Inc.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Loxo Oncology, Inc.	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib	PK: Cmax of Selpercatinib	Predose on Day 1 & 15 through Day 14 & 28
Primary	PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Selpercatinib	PK: AUC[0-8] of Selpercatinib	Predose on Day 1 & 15 through Day 14 & 28
Primary	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