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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: Completed Phase 1 study of Healthy, sponsored by Eli Lilly and Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PK: AUC0-t of Selpercatinib was reported.
Conditions Studied
Interventions
- DRUG Omeprazole
- DRUG Selpercatinib
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2018-09-13 |
| Phase | Phase 1 |
What the finished NCT05468164 record still lists
NCT05468164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05468164's enrollment target sits among peer trials
20 861st of 1090 higher than 194 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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