A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants

NCT ID: NCT05468164

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2018-09-13

Brief Summary

The main purpose of this study is to assess the effect of food on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it after a high-fat meal, and the effect of a change in gastric pH after multiple doses of omeprazole on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it when administered under fasted and fed conditions in healthy participants. The study will also evaluate the safety and tolerability of selpercatinib in healthy participants. The study will last up to 33 days excluding the screening period.

Conditions

Healthy

Study Design

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

Study Groups

Treatment Sequence 1: ABCD

Participants received:

• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state.
• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state.

Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Omeprazole

Intervention Type: DRUG

Administered orally

Treatment Sequence 2: ABDC

Participants received:

• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state.
• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state.

Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Omeprazole

Intervention Type: DRUG

Administered orally

Treatment Sequence 3: BACD

Participants received:

• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state.
• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state.

Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Omeprazole

Intervention Type: DRUG

Administered orally

Treatment Sequence 4: BADC

Participants received:

• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state.
• Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state.
• Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state.

Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Omeprazole

Intervention Type: DRUG

Administered orally

Interventions

Selpercatinib

Administered orally

Intervention Type: DRUG

Omeprazole

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3527723; LOXO-292

Eligibility Criteria

Inclusion Criteria

• Non-vasectomized, male participants must have agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 6 months after the last dosing. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dosing of study drug)
• If male, must have agreed not to donate sperm from the first dosing until 6 months after the last dosing
• Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria

• Had a history of gastritis, gastrointestinal tract or hepatic disorder or other clinical condition that might have, in the opinion of the Principal Investigator or designee, and as confirmed by the Sponsor, affected the absorption, distribution, biotransformation, or excretion of LOXO 292 or omeprazole

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

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

Celerion

Tempe, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2G-MC-JZJQ

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-RET-18015

Identifier Type: OTHER

Identifier Source: secondary_id

17752

Identifier Type: -

Identifier Source: org_study_id