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NCT06385119 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers.
A Phase 1 study of Healthy Volunteer, sponsored by Fore Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT06385119 is a Phase 1 study of Healthy Volunteer that has completed, run by Fore Biotherapeutics. The registered enrollment target is 28 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06385119, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Fore Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine the following in two parts: Part A * The effect of food on the single dose PK of plixorafenib administered with cobicistat. * The effect of cobicistat administration on the single dose PK of plixorafenib. * The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants. Part B * To examine the effect of a high-fat and a low-fat meal versus fasted state on the single dose PK of plixorafenib administered alone. * To examine the effect of a low-fat meal versus fasted state on the single dose PK of plixorafenib administered with cobicistat. * To determine the safety of plixorafenib administered alone or with cobicistat (low-fat meal only) in a single dose regimen.
Conditions Studied
Interventions
- DRUG Plixorafenib
- DRUG Cobicistat
Study Locations (1)
Texas
- PPD - Austin Research Unit - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2025-01-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06385119
The ClinicalTrials.gov registry entry for NCT06385119 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (86% lower). The listed sponsor is Fore Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Plixorafenib is the first listed.
NCT06385119 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06385119 about?
NCT06385119 is a clinical study titled "A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers.". The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine the following i...
What is the current status of trial NCT06385119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-04-24. Estimated completion is 2025-01-07.
What conditions does trial NCT06385119 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT06385119?
The interventions under investigation include: Plixorafenib (DRUG), Cobicistat (DRUG).
Who is sponsoring clinical trial NCT06385119?
This trial is sponsored by Fore Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06385119 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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