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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04887064
The ClinicalTrials.gov registry entry for NCT04887064 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (44% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.