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NCT05468164 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT05468164 is a Phase 1 study of Healthy that has completed, run by Eli Lilly and Company. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05468164, a Phase 1 study of Healthy, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG Omeprazole
  • DRUG Selpercatinib

Study Locations (1)

Arizona

  • Celerion - Tempe

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-05-31
Est. Completion 2018-09-13
Phase Phase 1

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT05468164

The ClinicalTrials.gov registry entry for NCT05468164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Omeprazole is the first listed.

NCT05468164 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT05468164 about?

NCT05468164 is a clinical study titled "A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants". 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 bl...

What is the current status of trial NCT05468164?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-05-31. Estimated completion is 2018-09-13.

What conditions does trial NCT05468164 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT05468164?

The interventions under investigation include: Omeprazole (DRUG), Selpercatinib (DRUG).

Who is sponsoring clinical trial NCT05468164?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05468164 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.