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NCT04887064 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
A Phase 1 study of Hepatic Impairment, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 5
- Study locations
NCT04887064: Completed Phase 1 study of Hepatic Impairment, sponsored by Amgen.
NCT04887064 is a Phase 1 study of Hepatic Impairment that has completed, run by Amgen. The registered enrollment target is 20 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (44% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04887064, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 5
- Study locations
Study Summary
The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function.
Conditions Studied
Interventions
- DRUG Sotorasib
Study Locations (5)
Florida
- Clinical Pharmacology Of Miami LLC - Miami
- Orlando Clinical Research Center - Orlando
Texas
- American Research Corporation - San Antonio
- Pinnacle Clinical Research - San Antonio - San Antonio
California
- Orange County Research Center - Tustin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2022-03-09 |
| Phase | Phase 1 |
What the finished NCT04887064 record still lists
NCT04887064 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 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Sotorasib is the first listed.
NCT04887064 lists 5 locations in 3 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT04887064 about?
NCT04887064 is a clinical study titled "Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment". The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function.
What is the current status of trial NCT04887064?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-04-22. Estimated completion is 2022-03-09.
What conditions does trial NCT04887064 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT04887064?
The interventions under investigation include: Sotorasib (DRUG).
Who is sponsoring clinical trial NCT04887064?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04887064 being conducted?
This trial has 5 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
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 NCT04887064's enrollment target sits among peer trials
20 40th of 48 higher than 8 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment 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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