A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants
- Registration Number
- NCT05468164
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Selpercatinib and omeprazole administered in ABDC treatment sequence. Selpercatinib Period 1: Single oral dose of Selpercatinib administered in fasted state. Period 2: Single oral dose of Selpercatinib administered in fed state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4. Selpercatinib and omeprazole administered in ABCD treatment sequence Omeprazole Period 1: Single oral dose of Selpercatinib administered in fasted state. Period 2: Single oral dose of Selpercatinib administered in fed state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4. Selpercatinib and omeprazole administered in ABCD treatment sequence Selpercatinib Period 1: Single oral dose of Selpercatinib administered in fasted state. Period 2: Single oral dose of Selpercatinib administered in fed state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4. Selpercatinib and omeprazole administered in ABDC treatment sequence. Omeprazole Period 1: Single oral dose of Selpercatinib administered in fasted state. Period 2: Single oral dose of Selpercatinib administered in fed state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4. Selpercatinib and omeprazole administered in BADC treatment sequence. Selpercatinib Period 1: Single oral dose of Selpercatinib administered in fed state. Period 2: Single oral dose of Selpercatinib administered in fasted state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4. Selpercatinib and omeprazole administered in BACD treatment sequence. Selpercatinib Period 1: Single oral dose of Selpercatinib administered in fed state. Period 2: Single oral dose of Selpercatinib administered in fasted state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4. Selpercatinib and omeprazole administered in BACD treatment sequence. Omeprazole Period 1: Single oral dose of Selpercatinib administered in fed state. Period 2: Single oral dose of Selpercatinib administered in fasted state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4. Selpercatinib and omeprazole administered in BADC treatment sequence. Omeprazole Period 1: Single oral dose of Selpercatinib administered in fed state. Period 2: Single oral dose of Selpercatinib administered in fasted state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib Pre-dose up to 168 hour post-dose PK: AUC0-t of Selpercatinib
PK: Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib Pre-dose up to 168 hour post-dose PK: AUC0-inf of Selpercatinib
PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib Pre-dose up to 168 hour post-dose PK: AUC%extrap of Selpercatinib
PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib Pre-dose up to 168 hour post-dose PK: Kel of Selpercatinib
PK: Maximum observed concentration (Cmax) of Selpercatinib Pre-dose up to 168 hour post-dose PK: Cmax of Selpercatinib
PK: Time to reach Cmax (Tmax) of Selpercatinib Pre-dose up to 168 hour post-dose PK: Tmax of Selpercatinib
PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib Pre-dose up to 168 hour post-dose PK: CL/F of Selpercatinib
PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib Pre-dose up to 168 hour post-dose PK: t½ of Selpercatinib
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States