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NCT05134350 · ClinicalTrials.gov registry record · Phase 1
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
A Phase 1 study of Healthy Volunteers, sponsored by Loxo Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05134350: Completed Phase 1 study of Healthy Volunteers, sponsored by Loxo Oncology.
NCT05134350 is a Phase 1 study of Healthy Volunteers that has completed, run by Loxo Oncology. The registered enrollment target is 10 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05134350, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Loxo Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.
Primary Outcome
PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method.
Conditions Studied
Interventions
- DRUG Omeprazole
- DRUG LOXO-305
Study Locations (1)
Florida
- Covance Clinical Research Unit - Daytona Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-02-06 |
| Est. Completion | 2020-03-23 |
| Phase | Phase 1 |
What the finished NCT05134350 record still lists
NCT05134350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Omeprazole is the first listed.
NCT05134350 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05134350 about?
NCT05134350 is a clinical study titled "Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants". The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.
What is the current status of trial NCT05134350?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-02-06. Estimated completion is 2020-03-23.
What conditions does trial NCT05134350 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05134350?
The interventions under investigation include: Omeprazole (DRUG), LOXO-305 (DRUG).
Who is sponsoring clinical trial NCT05134350?
This trial is sponsored by Loxo Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05134350 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05134350's enrollment target sits among peer trials
10 260th of 283 higher than 18 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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