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NCT05338502 · ClinicalTrials.gov registry record · Phase 1
Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05338502: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT05338502 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05338502, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
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.
Primary Outcome
PK: AUC0-t of Selpercatinib. The analysis of variance (ANOVA) model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric least squares (LS) means and the difference between treatment geometric LS means, as well as their corresponding 90% confidence intervals (CIs). The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA an
Interventions
- DRUG Omeprazole
- DRUG Selpercatinib
- DRUG Ranitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2019-09-03 |
| Phase | Phase 1 |
What the finished NCT05338502 record still lists
NCT05338502 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Omeprazole is the first listed.
NCT05338502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05338502 about?
NCT05338502 is a clinical study titled "Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants". 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 peri...
What is the current status of trial NCT05338502?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-07-08. Estimated completion is 2019-09-03.
What interventions are being tested in trial NCT05338502?
The interventions under investigation include: Omeprazole (DRUG), Selpercatinib (DRUG), Ranitidine (DRUG).
Who is sponsoring clinical trial NCT05338502?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05338502's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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