Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ranitidine; Drug: Selpercatinib; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05338502

LOXO-RET-19075 (Other Identifier)

17574

J2G-OX-JZJL (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to learn about how H2 antagonist (ranitidine) and proton pump inhibitor (PPI) (omeprazole) affect Selpercatinib in healthy participants. Information about safety and tolerability will be collected. The study will last up to about 9 weeks, inclusive of screening period.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or 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

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
• Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

160 milligram (mg) Selpercatinib

Experimental group

Description:

Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).

Treatment:

Drug: Selpercatinib

150 mg Ranitidine dosed with 160 mg Selpercatinib

Experimental group

Description:

Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).

Treatment:

Drug: Selpercatinib

Drug: Ranitidine

40 mg Omeprazole dosed with 160 mg Selpercatinib

Experimental group

Description:

Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).

Treatment:

Drug: Omeprazole

Drug: Selpercatinib