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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: Completed Phase 1 study of Healthy Volunteer, sponsored by Fore Biotherapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs).
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 |
What the finished NCT06385119 record still lists
NCT06385119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06385119's enrollment target sits among peer trials
28 79th of 112 higher than 34 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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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