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CompletedNCT06385119Updated Mar 27, 2026Results posted

A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.

A Phase 1 interventional study of Plixorafenib and Cobicistat in Healthy Participants, sponsored by Fore Biotherapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Fore Biotherapeutics · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.
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.

02

Conditions studied

  • Healthy Participants

Keywords

  • Healthy Volunteer
  • FORE Biotherapeutics
  • FORE8394
  • Plixorafenib
  • PLX8394
03

In context

Lead sponsor

Fore Biotherapeutics is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The participant is able to provide written .

  2. Healthy male or non-pregnant, non-lactating female participants aged 18 to 55 years, inclusive, with a 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 abnormalities at investigator's discretion in laboratory and urine analyses, and with normal organ function as defined below:

    • Normal renal function: ≥ 90 mL/min.
    • Normal liver enzymes and (≤ ).
    • , with interval ≤ 450 msec; at screening.

  3. Healthy female participants must be:

    1. Documented to be surgically sterile (surgical methods inclusive of hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) or (amenorrhea for ≥24 months without an alternative medical cause and FSH ≥30 mIU/mL).

      OR

    2. Using , 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.
  4. Male participants with female partners of 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.
  5. 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.
  6. The participant agrees to comply with all protocol requirements for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. The participant has a history of drug allergy or anaphylaxis, including known to any components of plixorafenib or cobicistat.
  2. The participant has a history of any condition(s) or gastrointestinal surgeries, including gallbladder procedures, which might affect drug absorption, metabolism, or excretion.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. The participant has donated blood in the past 90 days prior to screening or has poor peripheral venous access.
  10. The participant has a diagnosis of chronic or acute liver disease, for example, auto immune, alcoholic, or neoplastic liver disease.
  11. The participant has positive serostatus for , , or .
  12. Male partners of females participants who are pregnant.
  13. Female participant of who is pregnant, lactating, or planning to become pregnant within 90 days after the last dose of study drug.
  14. The participant has received an drug, biologic, or device within 3 months or 5.5 half-lives of the investigational drug (whichever is longer), before receiving study drug.
  15. 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 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.
  16. 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.
  17. The participant is part of the clinical staff personnel or a family member of the clinical site staff.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Treatment 1

    Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).

    Drug: Plixorafenib

  • Experimental
    Treatment 2

    Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).

    Drug: Plixorafenib · Drug: Cobicistat

  • Experimental
    Treatment 3

    Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).

    Drug: Plixorafenib · Drug: Cobicistat

  • Experimental
    Treatment A

    Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).

    Drug: Plixorafenib

  • Experimental
    Treatment B

    Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).

    Drug: Plixorafenib

  • Experimental
    Treatment C

    Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).

    Drug: Plixorafenib

  • Experimental
    Treatment D

    Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).

    Drug: Plixorafenib · Drug: Cobicistat

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs).

    Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs).

    Time frame: First dose of Plixorafenib to day 19 (Treatment Period 3).

  2. 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.

    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.

  3. 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.

    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.

  4. Maximum Observed Plasma Concentration (Cmax).

    Maximum observed 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.

  5. Time to Maximum Observed Plasma Concentration (Tmax).

    Time at which the maximum concentration was observed, 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.

  6. Terminal Elimination Rate Constant (λz).

    Terminal rate constant calculated from the terminal slope of the natural log-linear regression of concentration with time.

    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.

  7. Terminal Phase Half-life (t1/2).

    Terminal half-life, calculated as ln (2)/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.

  8. Apparent Oral Clearance (CL/F).

    Oral clearance, calculated as Dose/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.

  9. 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.

  10. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

07

Results

Posted Mar 27, 2026

Participant flow

1 Clinical site located in the United States.

Participant flow — Overall Study
MilestonePart A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4
Started2222224444
Completed2222224444
Not completed0000000000

Outcome measures

PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs).

Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs).

Time frame:
First dose of Plixorafenib to day 19 (Treatment Period 3).
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
ParticipantsTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Any treatment Emergent Adverse Events (TEAE)1112341
Related to Plixorafenib1111100
Related to Cobicistat0110000
Grade ≥3 TEAE0000000
Serious Adverse Event (SAE)0000000
TEAE Leading to Early Study Discontinuation0000000
Adverse Event of Special Interest (AESI)0000000
Death0000000
PrimaryArea 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.

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.
Reported as:
Mean · h*µg/mL
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t).
h*µg/mLTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t).49.02 ± 25.387168.31 ± 90.7189513.686 ± 115.45972.36 ± 41.4522120.376 ± 44.2094173.517 ± 65.8967474.421 ± 155.6191
PrimaryAUC 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.

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.
Reported as:
Mean · h*µg/mL
AUC From Time 0 Extrapolated to Infinity (AUC0-inf).
h*µg/mLTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
AUC From Time 0 Extrapolated to Infinity (AUC0-inf).46.588 ± 24.1108169.316 ± 91.6553514.824 ± 115.864374.02 ± 42.9613121.883 ± 45.6913173.964 ± 66.1065474.967 ± 155.8864
PrimaryMaximum Observed Plasma Concentration (Cmax).

Maximum observed 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.
Reported as:
Mean · µg/mL
Maximum Observed Plasma Concentration (Cmax).
µg/mLTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Maximum Observed Plasma Concentration (Cmax).11.481 ± 6.617123.272 ± 11.801449 ± 17.22812.416 ± 4.221324.61 ± 8.00728.13 ± 13.91466.12 ± 14.655
PrimaryTime to Maximum Observed Plasma Concentration (Tmax).

Time at which the maximum concentration was observed, 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.
Reported as:
Mean · h
Time to Maximum Observed Plasma Concentration (Tmax).
hTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Time to Maximum Observed Plasma Concentration (Tmax).2.668 ± 0.77723.3 ± 0.876.2 ± 1.82.935 ± 1.33482.676 ± 0.79723.443 ± 1.09183.679 ± 0.6283
PrimaryTerminal Elimination Rate Constant (λz).

Terminal rate constant calculated from the terminal slope of the natural log-linear regression of concentration with time.

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.
Reported as:
Mean · 1/h
Terminal Elimination Rate Constant (λz).
1/hTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Terminal Elimination Rate Constant (λz).0.05129 ± 0.0205930.06208 ± 0.0367370.06057 ± 0.0240430.04381 ± 0.0316880.04046 ± 0.0197890.05121 ± 0.0208870.05538 ± 0.02338
PrimaryTerminal Phase Half-life (t1/2).

Terminal half-life, calculated as ln (2)/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.
Reported as:
Mean · h
Terminal Phase Half-life (t1/2).
hTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Terminal Phase Half-life (t1/2).15.603 ± 6.152521.036 ± 23.460814.285 ± 9.479623.976 ± 17.164122.909 ± 14.037417.009 ± 10.300316.868 ± 11.8901
PrimaryApparent Oral Clearance (CL/F).

Oral clearance, calculated as Dose/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.
Reported as:
Mean · L/h
Apparent Oral Clearance (CL/F).
L/hTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Apparent Oral Clearance (CL/F).25.521 ± 14.69217.211 ± 4.1661.837 ± 0.437415.868 ± 7.57788.301 ± 2.86395.628 ± 1.4022.123 ± 0.8305
PrimaryApparent 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.
Reported as:
Mean · L
Apparent Volume of Distribution (Vz/F).
LTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Apparent Volume of Distribution (Vz/F).631.925 ± 519.1238208.855 ± 307.579636.971 ± 22.4434442.143 ± 222.1673237.592 ± 87.5592124.526 ± 53.167145.258 ± 23.8247
PrimaryLag 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.
Reported as:
Mean · h
Lag Time of Absorption or the Time Delay Between Time 0 and the First Observed Quantifiable Concentration, Obtained by Inspection.
hTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Lag Time of Absorption or the Time Delay Between Time 0 and the First Observed Quantifiable Concentration, Obtained by Inspection.0 ± 00 ± 00 ± 00 ± 00 ± 00 ± 00 ± 0
SecondaryCumulative 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.

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.
Reported as:
Mean · mg
Cumulative Amount of Plixorafenib Excreted in Urine(Ae)
mgTreatment 1Treatment 2Treatment 3
Cumulative Amount of Plixorafenib Excreted in Urine(Ae)0.11749 ± 0.0577490.46969 ± 0.2297641.82134 ± 0.865302
SecondaryPercent 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.

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.
Reported as:
Mean · percent
Percent of Dose Excreted in Urine in 48 Hours.
percentTreatment 1Treatment 2Treatment 3
Percent of Dose Excreted in Urine in 48 Hours.0.01305 ± 0.0064170.05219 ± 0.0255290.20237 ± 0.096145

Adverse events

Collected over Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment 10/12 (0%)0/12 (0%)1/12 (8.3%)
Treatment 20/12 (0%)0/12 (0%)1/12 (8.3%)
Treatment 30/12 (0%)0/12 (0%)1/12 (8.3%)
Treatment A0/12 (0%)0/12 (0%)2/12 (16.7%)
Treatment B0/12 (0%)0/12 (0%)3/12 (25%)
Treatment C0/12 (0%)0/12 (0%)4/12 (33.3%)
Treatment D0/12 (0%)0/12 (0%)1/12 (8.3%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventTreatment 1Treatment 2Treatment 3Treatment ATreatment BTreatment CTreatment D
Abdominal PainGastrointestinal disorders0/120/120/121/122/120/120/12
DizzinessNervous system disorders1/120/120/120/120/120/120/12
DysgeusiaNervous system disorders0/121/120/120/120/120/120/12
AlopeciaSkin and subcutaneous tissue disorders0/120/121/120/120/120/120/12
VertigoEar and labyrinth disorders0/120/120/120/121/120/120/12
DiarrhoeaGastrointestinal disorders0/121/120/120/121/120/120/12
NauseaGastrointestinal disorders0/120/120/120/121/120/120/12
Medical device site dermatitisGeneral disorders0/120/120/120/120/121/120/12
Non-cardiac chest painGeneral disorders0/120/120/120/121/120/120/12
Viral upper respiratory tract infectionInfections and infestations0/120/120/121/120/120/120/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Part A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4Total
<=18 years00000000000
Between 18 and 65 years222222444428
>=65 years00000000000
Sex: Female, Male
Sex: Female, Male(Participants)Part A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4Total
Female000011024210
Male222211420218
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Part A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4Total
Black or African American211011223316
White011211221112
Region of Enrollment
Region of Enrollment(participants)Part A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4Total
United States222222444428
Height
Height(centimeters)Part A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4Total
Mean185.55 ± 3.748174.65 ± 3.323177.30 ± 4.808184.4 ± 13.294166.10 ± 9.192166.40 ± 4.808176.48 ± 7.121165.55 ± 7.059174.25 ± 5.482170.38 ± 9.404168.12 ± 30.40
Weight
Weight(kilograms)Part A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4Total
Mean98.75 ± 5.72883.55 ± 2.47583.00 ± 0.84991.95 ± 21.00170.70 ± 9.33473.50 ± 11.59783.35 ± 11.14874.95 ± 4.66482.03 ± 10.13672.65 ± 9.94180.53 ± 11.03
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)Part A: Sequence 1Part A: Sequence 2Part A: Sequence 3Part A: Sequence 4Part A: Sequence 5Part A: Sequence 6Part B: Sequence 1Part B: Sequence 2Part B: Sequence 3Part B: Sequence 4Total
Mean28.65 ± 0.49527.40 ± 1.83826.40 ± 1.13126.80 ± 2.26325.55 ± 0.49526.45 ± 2.61626.83 ± 3.74627.40 ± 1.90326.90 ± 1.78024.94 ± 2.45026.68 ± 2.098
08

Study locations

1 site
  • PPD - Austin Research Unit
    Austin, Texas 78744, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06385119
Lead sponsor
Fore Biotherapeutics
Responsible party
Sponsor
First posted
Apr 25, 2024
Start date
Apr 24, 2024
Primary completion
Dec 22, 2024
Completion
Jan 7, 2025
Results posted
Mar 27, 2026
Last update
Mar 27, 2026

Study contacts

Stacie P Shepherd, MD, PhD
study chair · Fore Biotherapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: PLX8394 · Cobicistat

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