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A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers.
NCT06385119 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fore Biotherapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06385119 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06385119?
The interventions under investigation include: Plixorafenib (DRUG), Cobicistat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06385119?
This trial is sponsored by Fore Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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