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

Healthy Clinical Trial

Official title:

An Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468164
• Other study ID #: 17752
• Secondary ID: J2G-MC-JZJQLOXO-
• Status: Completed
• Phase: Phase 1
• Start date: May 31, 2018
• Est. completion date: September 13, 2018

Study information

• Verified date: July 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 13, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Selpercatinib
Administered orally
• Omeprazole
Administered orally

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib	PK: AUC0-t of Selpercatinib	Pre-dose up to 168 hour post-dose
Primary	PK: Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib	PK: AUC0-inf of Selpercatinib	Pre-dose up to 168 hour post-dose
Primary	PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib	PK: AUC%extrap of Selpercatinib	Pre-dose up to 168 hour post-dose
Primary	PK: Maximum observed concentration (Cmax) of Selpercatinib	PK: Cmax of Selpercatinib	Pre-dose up to 168 hour post-dose
Primary	PK: Time to reach Cmax (Tmax) of Selpercatinib	PK: Tmax of Selpercatinib	Pre-dose up to 168 hour post-dose
Primary	PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib	PK: Kel of Selpercatinib	Pre-dose up to 168 hour post-dose
Primary	PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib	PK: CL/F of Selpercatinib	Pre-dose up to 168 hour post-dose
Primary	PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib	PK: t½ of Selpercatinib	Pre-dose up to 168 hour post-dose