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NCT05497557 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05497557 is a Phase 1 study of Healthy Volunteers that has completed, run by Amgen. The registered enrollment target is 16 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05497557, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.
Conditions Studied
Interventions
- DRUG Sotorasib
- DRUG Omeprazole
Study Locations (1)
Texas
- Labcorp Clinical Research Unit Inc. - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-07-14 |
| Est. Completion | 2022-09-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05497557
The ClinicalTrials.gov registry entry for NCT05497557 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Sotorasib is the first listed.
NCT05497557 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05497557 about?
NCT05497557 is a clinical study titled "A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers". The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.
What is the current status of trial NCT05497557?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-07-14. Estimated completion is 2022-09-08.
What conditions does trial NCT05497557 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05497557?
The interventions under investigation include: Sotorasib (DRUG), Omeprazole (DRUG).
Who is sponsoring clinical trial NCT05497557?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05497557 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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