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

Healthy Clinical Trial

Official title:

An Open-Label, Randomized Study to Evaluate the Relative Bioavailability of Selpercatinib in 3 Formulations for Pediatric Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136404
• Other study ID #: 17821
• Secondary ID: J2G-MC-JZJU
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2021
• Est. completion date: March 14, 2022

Study information

• Verified date: April 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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)

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	LabCorp CRU, Inc.	Daytona Beach	Florida

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, 8 & 15 through Day 7, 14 & 21
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, 8 & 15 through Day 7, 14 & 21
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, 8 & 15 through Day 7, 14 & 21
Primary	PK: Time to Maximum Observed Concentration (Tmax) of Selpercatinib	PK: Tmax of Selpercatinib	Predose on Day 1, 8 & 15 through Day 7, 14 & 21