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

NCT ID: NCT05136404

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2022-03-14

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Selpercatinib Sequence A:

Period 1: 20 milligram (mg) Selpercatinib capsule single oral dose administered orally on Day 1.

Period 2: 20 mg per milliliter (mL) Selpercatinib Powder for Oral suspension (PFOS) single oral suspension dose on Day 8.

Period 3: 20 mg/mL Selpercatinib Ready to Use (RTU) single oral suspension on Day 15.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Selpercatinib Sequence B

Period 1: 20 mg/mL Selpercatinib RTU single oral suspension on Day 1.

Period 2: 20 mg Selpercatinib capsule single oral dose administered orally on Day 8.

Period 3: 20 mg/mL PFOS single oral suspension dose on Day 15.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Selpercatinib Sequence C

Period 1: 20 mg/mL PFOS single oral suspension dose on Day 1.

Period 2: 20 mg/mL Selpercatinib RTU single oral suspension on Day 8.

Period 3: 20 mg Selpercatinib capsule single oral dose administered orally on Day 15.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Interventions

Selpercatinib

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3527723; LOXO-292

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

LabCorp CRU, Inc.

Daytona Beach, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2G-MC-JZJU

Identifier Type: OTHER

Identifier Source: secondary_id

17821

Identifier Type: -

Identifier Source: org_study_id