Healthy ParticipantsPhase 1NCT06385119
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.
A Phase 1 study testing Plixorafenib and Cobicistat in people with Healthy Participants, run by Fore Biotherapeutics at 1 site in United States.
Trial summary
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Plixorafenib and Cobicistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 7 Jan 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant is able to provide written informed consent.
- Healthy male or non-pregnant, non-lactating female participants aged 18 to 55 years, inclusive, with a BMI of 18 kg/m2 or greater, but less than 30 kg/m2. The participant is considered by the investigator to be in good general health status as determined by physical examination, vital signs, temperature, medical history, no clinically significant abnormalities at investigator's discretion in laboratory and urine analyses, and with normal organ function as defined below:
- Normal renal function: creatinine clearance ≥ 90 mL/min.
- Normal liver enzymes and bilirubin (≤ ULN).
- ECG, with QTcF interval ≤ 450 msec; at screening.
- Healthy female participants must be:
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- Documented to be surgically sterile (surgical methods inclusive of hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) or postmenopausal (amenorrhea for ≥24 months without an alternative medical cause and FSH ≥30 mIU/mL).
- OR
- Using contraception, including 1 highly effective nonhormonal methods (eg, intrauterine device) in combination with a barrier contraception (eg, male or female condoms, diaphragm, spermicide, etc.) from start of plixorafenib administration until 30 days after the last plixorafenib administration, and having a negative serum or urine β-hCG pregnancy test (with a sensitivity of at least 25 mIU/mL) at screening and check in.
- Male participants with female partners of childbearing potential must be sterile (confirmed by documented azoospermia 90 days after the procedure) or agree to use (from check-in until 90 days after discharge) one of the following approved methods of contraception: male condom with spermicide; sterile sexual partner (males must still agree to use condom with their surgically sterile female partner if unable to provide documentation of partner's sterility); or practice abstinence (abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant, periodic abstinence won't be allowed); or use of an intrauterine device with spermicide by female sexual partner; a female condom with spermicide; a contraceptive sponge with spermicide; an intravaginal system; a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives.
- Male participants must refrain from sperm donation and female participants must refrain from egg donation from check-in until 90 days after discharge from the study.
- The participant agrees to comply with all protocol requirements for the duration of the study.
Who cannot join
- The participant has a history of clinically significant drug allergy or anaphylaxis, including known hypersensitivity to any components of plixorafenib or cobicistat.
- The participant has a history of any condition(s) or gastrointestinal surgeries, including gallbladder procedures, which might affect drug absorption, metabolism, or excretion.
- The participant has clinical evidence or a history of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurologic, or other chronic disease as judged by the investigator.
- The participant has a history of psychiatric disease, a suicidal attempt, hospitalization for psychiatric disease, a period of disability due to a psychiatric disease, or administers treatment to control the condition. Psychiatric disease includes major depression, bipolar disorder, or psychosis for ≥3 months.
- The participant has a history or other evidence of illness, test abnormalities, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study.
- The participant has any history of alcoholism or drug abuse, or excessive alcohol consumption (regular alcohol intake >21 units per week for male participants and >14 units of alcohol per week for female participants) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits) within 3 months before screening.
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- The participant has positive results on screen for drugs of abuse or alcohol (Section 6.2.3 [Other analyses]) at screening visit or Day -1.
- The participant is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine pouch (eg ZYN), nicotine patch, nicotine chewing gum, mock cigarettes, vape cigarette alternatives, or inhalers), marijuana, and cannabinoids within 1 year before the first dose of study drug.
- The participant has donated blood in the past 90 days prior to screening or has poor peripheral venous access.
- The participant has a diagnosis of chronic or acute liver disease, for example, auto immune, alcoholic, or neoplastic liver disease.
- The participant has positive serostatus for HIV, HCV, or HBV.
- Male partners of females participants who are pregnant.
- Female participant of childbearing potential who is pregnant, lactating, or planning to become pregnant within 90 days after the last dose of study drug.
- The participant has received an investigational drug, biologic, or device within 3 months or 5.5 half-lives of the investigational drug (whichever is longer), before receiving study drug.
- The participant has used any systemic medications, including vitamins and over the counter items, during the 14 days (or 5 times the elimination half-life of the medication, whichever is longer) before receiving study drug or will require their use during the study. Inducers and inhibitors of metabolic enzymes and/or transporters (in particular CYP3A inhibitors or inducers, P-gp, and BCRP), and herbal preparations, nutritional supplements (eg, St. John's Wort), or foods, including grapefruit juice, grapefruit/grapefruit-related citrus fruits (eg, Seville oranges, pomelos), which have been shown to produce metabolic enzyme or transporter induction or inhibition, are prohibited before 5 half-lives of the investigational drug prior to check-in (Day -1). Paracetamol ≤ 3000 mg/day will be allowed up to 2 consecutive days before dosing and during the outpatient phase of the study, as needed.
- The participant has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within 30 days prior to the first dosing and throughout the study.
- The participant is part of the clinical staff personnel or a family member of the clinical site staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 2-Part, Single Dose, Crossover Study to Examine the Effect of Food and Cobicistat Administration on the Pharmacokinetics and Safety of Plixorafenib in Healthy Participants.
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants. 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
Read more
- 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.
Read the detailed description
Part A is an open-label, randomized, single dose, 3-treatment, 3-period, crossover design. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered either with or without cobicistat, under fasting conditions or following a standardized high-fat/high-calorie meal. PK blood and urine samples will be collected at pre-dose and at several post-dose time points. There will be a washout period between doses. Participants will be confined for total of 19 days.
Part B is an open-label, randomized, single dose, 4-treatment, 3-period, crossover design. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered without cobicistat, under fasting conditions, following a standardized high-fat/high-calorie meal without cobicistat, or following a low-fat meal with or without cobicistat. PK blood and urine samples will be collected at pre-dose and at several post-dose time points. There will be a washout period between doses. participants will be confined for total of 19 days.
- Conditions
- Healthy Participants
- Being tested
- Plixorafenib, Cobicistat
- Keywords
- Healthy Volunteer, FORE Biotherapeutics, FORE8394, Plixorafenib, PLX8394
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlixorafenibDrug
Also called FORE8394
Oral Tablet
CobicistatDrug
Also called Tybost
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state). Receives: Drug: Plixorafenib |
| Treatment 2 | Experimental | Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state). Receives: Drug: Plixorafenib; Drug: Cobicistat |
| Treatment 3 | Experimental | Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state). Receives: Drug: Plixorafenib; Drug: Cobicistat |
| Treatment A | Experimental | Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state). Receives: Drug: Plixorafenib |
| Treatment B | Experimental | Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal). Receives: Drug: Plixorafenib |
| Treatment C | Experimental | Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal). Receives: Drug: Plixorafenib |
| Treatment D | Experimental | Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal). Receives: Drug: Plixorafenib; Drug: Cobicistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs).
Measured: First dose of Plixorafenib to day 19 (Treatment Period 3).
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t).
Area under the concentration versus time curve from time 0 to the last quantifiable concentration within the dosing interval.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
AUC From Time 0 Extrapolated to Infinity (AUC0-inf).
Area under the concentration versus time curve from time 0 extrapolated to infinity calculated as AUC0-t + Clast/λz, where Clast is the last quantifiable concentration and lambda z is the terminal rate constant.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Maximum Observed Plasma Concentration (Cmax).
Maximum observed concentration, obtained by inspection.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Time to Maximum Observed Plasma Concentration (Tmax).
Time at which the maximum concentration was observed, obtained by inspection.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Terminal Elimination Rate Constant (λz).
Terminal rate constant calculated from the terminal slope of the natural log-linear regression of concentration with time.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Terminal Phase Half-life (t1/2).
Terminal half-life, calculated as ln (2)/λz.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Apparent Oral Clearance (CL/F).
Oral clearance, calculated as Dose/AUC0 inf.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Apparent Volume of Distribution (Vz/F).
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Lag Time of Absorption or the Time Delay Between Time 0 and the First Observed Quantifiable Concentration, Obtained by Inspection.
Measured: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Secondary outcomes (2)
Cumulative Amount of Plixorafenib Excreted in Urine(Ae)
The cumulative amount of plixorafenib in urine from 0 to 48 hours, Ae,48, was calculated for the Part A participants only as the sum between 0 and 48 hours of the product of the urine concentration and the urine volume for each collection interval by participant for each treatment.
Measured: Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period.
Percent of Dose Excreted in Urine in 48 Hours.
The percent of the dose excreted in urine in 48 hours (fe,48%) was calculated as Ae,48*100/Dose.
Measured: Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start24 Apr 2024
- Primary completion22 Dec 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fore Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacie P Shepherd, MD, PhD, Study chair, Fore Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385119
- Sponsor's protocol ID
- F8394-101
- Status last verified
- Mar 2026
- First submitted
- 15 Apr 2024
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 2-Part, Single Dose, Crossover Study to Examine the Effect of Food and Cobicistat Administration on the Pharmacokinetics and Safety of Plixorafenib in Healthy Participants.
- ClinicalTrials.gov ID
- NCT06385119
- Acronym / sponsor ID
- F8394-101
- Conditions
- Healthy Participants
- Keywords
- Healthy Volunteer, FORE Biotherapeutics, FORE8394, Plixorafenib, PLX8394
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fore BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants. 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.
Detailed description
Part A is an open-label, randomized, single dose, 3-treatment, 3-period, crossover design. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered either with or without cobicistat, under fasting conditions or following a standardized high-fat/high-calorie meal. PK blood and urine samples will be collected at pre-dose and at several post-dose time points. There will be a washout period between doses. Participants will be confined for total of 19 days.
Part B is an open-label, randomized, single dose, 4-treatment, 3-period, crossover design. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered without cobicistat, under fasting conditions, following a standardized high-fat/high-calorie meal without cobicistat, or following a low-fat meal with or without cobicistat. PK blood and urine samples will be collected at pre-dose and at several post-dose time points. There will be a washout period between doses. participants will be confined for total of 19 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: PlixorafenibTreatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state). |
| Treatment 2 | Experimental | Drug: Plixorafenib, Drug: CobicistatTreatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state). |
| Treatment 3 | Experimental | Drug: Plixorafenib, Drug: CobicistatTreatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state). |
| Treatment A | Experimental | Drug: PlixorafenibTreatment A: 900 mg plixorafenib administered after overnight fast (fasted state). |
| Treatment B | Experimental | Drug: PlixorafenibTreatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal). |
| Treatment C | Experimental | Drug: PlixorafenibTreatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal). |
| Treatment D | Experimental | Drug: Plixorafenib, Drug: CobicistatTreatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- The participant is able to provide written informed consent.
- Healthy male or non-pregnant, non-lactating female participants aged 18 to 55 years, inclusive, with a BMI of 18 kg/m2 or greater, but less than 30 kg/m2. The participant is considered by the investigator to be in good general health status as determined by physical examination, vital signs, temperature, medical history, no clinically significant abnormalities at investigator's discretion in laboratory and urine analyses, and with normal organ function as defined below:
- Healthy female participants must be:
- OR
- Male participants with female partners of childbearing potential must be sterile (confirmed by documented azoospermia 90 days after the procedure) or agree to use (from check-in until 90 days after discharge) one of the following approved methods of contraception: male condom with spermicide; sterile sexual partner (males must still agree to use condom with their surgically sterile female partner if unable to provide documentation of partner's sterility); or practice abstinence (abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant, periodic abstinence won't be allowed); or use of an intrauterine device with spermicide by female sexual partner; a female condom with spermicide; a contraceptive sponge with spermicide; an intravaginal system; a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives.
Key exclusion criteria (17 listed)
- The participant has a history of clinically significant drug allergy or anaphylaxis, including known hypersensitivity to any components of plixorafenib or cobicistat.
- The participant has a history of any condition(s) or gastrointestinal surgeries, including gallbladder procedures, which might affect drug absorption, metabolism, or excretion.
- The participant has clinical evidence or a history of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurologic, or other chronic disease as judged by the investigator.
- The participant has a history of psychiatric disease, a suicidal attempt, hospitalization for psychiatric disease, a period of disability due to a psychiatric disease, or administers treatment to control the condition. Psychiatric disease includes major depression, bipolar disorder, or psychosis for ≥3 months.
- The participant has a history or other evidence of illness, test abnormalities, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlixorafenibAlso: FORE8394Oral Tablet | Drug | Treatment 1, Treatment 2, Treatment 3, Treatment A, Treatment B, Treatment C, Treatment D |
| CobicistatAlso: TybostOral Tablet | Drug | Treatment 2, Treatment 3, Treatment D |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Time frame: First dose of Plixorafenib to day 19 (Treatment Period 3).
Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs).
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Area under the concentration versus time curve from time 0 to the last quantifiable concentration within the dosing interval.
AUC From Time 0 Extrapolated to Infinity (AUC0-inf).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Area under the concentration versus time curve from time 0 extrapolated to infinity calculated as AUC0-t + Clast/λz, where Clast is the last quantifiable concentration and lambda z is the terminal rate constant.
Maximum Observed Plasma Concentration (Cmax).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Maximum observed concentration, obtained by inspection.
Time to Maximum Observed Plasma Concentration (Tmax).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Time at which the maximum concentration was observed, obtained by inspection.
Terminal Elimination Rate Constant (λz).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Terminal rate constant calculated from the terminal slope of the natural log-linear regression of concentration with time.
Terminal Phase Half-life (t1/2).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Terminal half-life, calculated as ln (2)/λz.
Apparent Oral Clearance (CL/F).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Oral clearance, calculated as Dose/AUC0 inf.
Apparent Volume of Distribution (Vz/F).
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Lag Time of Absorption or the Time Delay Between Time 0 and the First Observed Quantifiable Concentration, Obtained by Inspection.
Time frame: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
2 secondary outcomes
Cumulative Amount of Plixorafenib Excreted in Urine(Ae)
Time frame: Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period.
Percent of Dose Excreted in Urine in 48 Hours.
Time frame: Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacie P Shepherd, MD, PhD study chair
Fore Biotherapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Plixorafenib and Cobicistat in people with Healthy Participants, run by Fore Biotherapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs). (time frame: First dose of Plixorafenib to day 19 (Treatment Period 3).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.