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NCT05048784 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 145
- Enrollment target
NCT05048784: Completed Phase 1 study, sponsored by Amgen.
NCT05048784 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 145 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (142% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05048784, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 145 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
Primary Outcome
Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma pharmacokinetic (PK) parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified.
Interventions
- DRUG Sotorasib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2022-02-18 |
| Phase | Phase 1 |
What the finished NCT05048784 record still lists
NCT05048784 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (142% higher).
The record links to 0 conditions, and to 1 intervention - of which Sotorasib is the first listed.
NCT05048784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05048784 about?
NCT05048784 is a clinical study titled "A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants". The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
What is the current status of trial NCT05048784?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2021-08-16. Estimated completion is 2022-02-18.
What interventions are being tested in trial NCT05048784?
The interventions under investigation include: Sotorasib (DRUG).
Who is sponsoring clinical trial NCT05048784?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05048784's enrollment target sits among peer trials
145 391st of 2000 higher than 1,607 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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