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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Omeprazole; Drug: Selpercatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05468164

17752

J2G-MC-JZJQ (Other Identifier)

LOXO-RET-18015 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Treatment Sequence 1: ABCD

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib

Drug: Omeprazole

Treatment Sequence 2: ABDC

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib

Drug: Omeprazole

Treatment Sequence 3: BACD

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib

Drug: Omeprazole

Treatment Sequence 4: BADC

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib

Drug: Omeprazole