HealthyPhase 1ERBANCT05446142

A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations

A Phase 1 study testing Encorafenib capsule formulation (CAP), Encorafenib first formulation and Encorafenib second formulation in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Encorafenib capsule formulation (CAP), Encorafenib first formulation and Encorafenib second formulation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2022to 30 Sep 2022
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants must be male or female of non-childbearing potential of 18 years of age or older, inclusive, at the time of signing the informed consent document.
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body Mass Index of 17.5 to 30.5 kg/meters squared; and a body weight >50 kg (110 lb).
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and the protocol.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. Evidence of any active and uncontrolled bacterial or viral infection.
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
History of human immunodeficiency virus infection, hepatitis B, or hepatitis C; positive testing for human immunodeficiency virus, Hepatitis B surface antigen, Hepatitis B core antibody or hepatitis C virus antibody. Hepatitis B vaccination is allowed.
Positive COVID-19 test at first admission.
Other medical or psychiatric conditions, laboratory test abnormalities, other conditions or situations related to COVID-19 pandemic or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or non-prescription medications within 7 days prior to the first dose of encorafenib with the exception of moderate/potent CYP3A inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose.

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History of known sensitivity to rabeprazole, substituted benzimidazoles or to any component of the rabeprazole formulation.
Previous administration with an investigational product (drug or vaccine) within 30 days.
Known hypersensitivity to encorafenib or its excipients.
A positive urine drug or cotinine test.
Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
Baseline standard 12 lead electrocardiogram that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Aspartate transaminase or alanine aminotransferase level ≥ 1.5 × upper limit of normal.
Total bilirubin level ≥1.5 × upper limit of normal.
Estimated glomerular filtration rate <60 ml/min/1.73 m2

Trial locations and contacts

1 site in 1 country.

United States1 site

New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF TWO NEW ENCORAFENIB FORMULATIONS RELATIVE TO THE CURRENT FORMULATION AND TO EVALUATE THE EFFECT OF A PROTON-PUMP INHIBITOR ON ENCORAFENIB PLASMA PHARMACOKINETICS

Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations

Read the detailed description

In order to decrease the size of the current formulated encorafenib capsule and improve the physical stability, 2 new encorafenib tablet formulations have been developed.

This study is intended to select the optimal tablet formulation for commercialization based on the tablet pharmacokinetics.

A preliminary assessment of the effect of a proton-pump inhibitor on the pharmacokinetics of the 2 encorafenib tablet formulations will also be conducted to assist in the formulation selection.

Conditions: Healthy
Being tested: Encorafenib capsule formulation (CAP), Encorafenib first formulation, Encorafenib second formulation, Rabeprazole tablet
Keywords: Encorafenib, Rabeprazole, Healthy adult participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Encorafenib capsule formulation (CAP)Drug
A single encorafenib dose of the CAP formulation
Encorafenib first formulationDrug
first formulation
Encorafenib second formulationDrug
second formulation
Rabeprazole tabletDrug
Proton-pump inhibitor

Study groups in NCT05446142
Study group	Role	What they receive
Four Period Treatment Sequence: PPI Effect	Experimental	Participants will receive a single encorafenib dose formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the formulation after administration of 20 mg rabeprazole every evening for 5 days. Receives: Drug: Encorafenib capsule formulation (CAP); Drug: Encorafenib first formulation; Drug: Encorafenib second formulation; Drug: Rabeprazole tablet
Four Period Treatment Sequence: PPI Effect Second Formulation	Experimental	Participants will receive a single encorafenib dose of the second formulation, a single encorafenib dose of the second formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the second formulation after administration of 20 mg rabeprazole every evening for 5 days. Receives: Drug: Encorafenib capsule formulation (CAP); Drug: Encorafenib first formulation; Drug: Encorafenib second formulation; Drug: Rabeprazole tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
AUCinf for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by AUClast + (Clast/kel), where AUClast was the area under the plasma concentration-time profile from time zero to last quantifiable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was first-order elimination rate constant.
Measured: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Maximum Observed Plasma Concentration (Cmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Cmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data.
Measured: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Area Under the Plasma Concentration-Time Profile From Time Zero to Last Quantifiable Concentration (AUClast) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
AUClast for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated using Linear/Log trapezoidal method.
Measured: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Secondary outcomes (8)

Time for Cmax (Tmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Tmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data as time of first occurrence.
Measured: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Terminal Half-Life (t½) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
t½ for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Measured: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Apparent Clearance (CL/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
CL/F for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Dose/AUCinf after oral dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Apparent Volume of Distribution (Vz/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Vz/F for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Dose/(AUCinf * kel) after oral dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Any AEs occurring following start of treatment were considered as treatment emergent adverse event (TEAE). Events that occurred during follow-up within the lag time of up to 28 days after the last encorafenib dose were counted as treatment emergent and attributed to the last treatment taken. Events that occurred during the washout period (up to 28 days from the last treatment) between study periods were counted as treatment emergent and attributed to the previous treatment taken.
Measured: Baseline up to Day 28 after the last encorafenib dose (the total duration of the study was approximately 60 days from baseline)
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Haematological, clinical chemistry (serum) and urinalysis safety tests were assessed against the criteria specified in the sponsor reporting standards. The assessment did not take into account whether each participants's baseline test result was within or outside the laboratory reference range for the particular laboratory parameter. The baseline measurement for safety laboratory tests for all periods was the predose measurement on Day -1 of Period 1. Only those categories in which at least 1 participant had data were reported.
Measured: Baseline, and at early discontinuation or at the discretion of the investigator (the total duration of the study was approximately 60 days from baseline)
Number of Participants Meeting Vital Signs Categorical Criteria
Supine blood pressure (BP) and pulse rate (PR) were measured at times specified. For Periods 1 to 3, the baseline measurement was the predose measurement on Day -1 of each period. For Period 4, the baseline measurement was the predose measurement on Day -1 of Period 3. The reported categories included: systolic blood pressure (SBP)>=90mmHg; change from baseline (CFB) in SBP>=30mmHg; diastolic blood pressure (DBP)<50mmHg; CFB in DBP>=20mmHg; PR<40 beats per minute (bpm) or PR>120bpm. Only those categories in which at least 1 participant had data were provided.
Measured: Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)
Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
Absolute values and changes from baseline in PR, QT, QRS, heart rate and QTcF were summarized by protocol pre-defined categorization criterion. QTcF were derived using Fridericia's heart rate correction formula. For each period, triplicate ECGs were conducted predose on Day 1; all other ECG measurements were single ECGs. The baseline ECG value was the average of the triplicate ECG measurements collected before dose administration on Day 1. Changes from baseline were defined as the change between the postdose ECG measurement and the derived baseline ECG.
Measured: Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202230 Sep 2022

First posted6 Jul 2022
Study start1 Jul 2022
Primary completion30 Sep 2022
Study completion30 Sep 2022

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 HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05446142
Sponsor's protocol ID: C4221024
Acronym: ERBA
Status last verified: Jul 2023
First submitted: 1 Jul 2022
Last updated: 23 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF TWO NEW ENCORAFENIB FORMULATIONS RELATIVE TO THE CURRENT FORMULATION AND TO EVALUATE THE EFFECT OF A PROTON-PUMP INHIBITOR ON ENCORAFENIB PLASMA PHARMACOKINETICS
ClinicalTrials.gov ID: NCT05446142
Acronym / sponsor ID: ERBA / C4221024
Conditions: Healthy
Keywords: Encorafenib, Rabeprazole, Healthy adult participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Ono Pharmaceutical Co., Ltd., Pierre Fabre Laboratories
Study start: 1 Jul 2022 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 6 Jul 2022 (actual)
Results: Posted 23 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations

Detailed description

In order to decrease the size of the current formulated encorafenib capsule and improve the physical stability, 2 new encorafenib tablet formulations have been developed.

This study is intended to select the optimal tablet formulation for commercialization based on the tablet pharmacokinetics.

A preliminary assessment of the effect of a proton-pump inhibitor on the pharmacokinetics of the 2 encorafenib tablet formulations will also be conducted to assist in the formulation selection.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Four Period Treatment Sequence: PPI Effect	Experimental	Drug: Encorafenib capsule formulation (CAP), Drug: Encorafenib first formulation, Drug: Encorafenib second formulation, Drug: Rabeprazole tabletParticipants will receive a single encorafenib dose formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the formulation after administration of 20 mg rabeprazole every evening for 5 days.
Four Period Treatment Sequence: PPI Effect Second Formulation	Experimental	Drug: Encorafenib capsule formulation (CAP), Drug: Encorafenib first formulation, Drug: Encorafenib second formulation, Drug: Rabeprazole tabletParticipants will receive a single encorafenib dose of the second formulation, a single encorafenib dose of the second formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the second formulation after administration of 20 mg rabeprazole every evening for 5 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants must be male or female of non-childbearing potential of 18 years of age or older, inclusive, at the time of signing the informed consent document.
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body Mass Index of 17.5 to 30.5 kg/meters squared; and a body weight >50 kg (110 lb).
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and the protocol.

Key exclusion criteria (15 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. Evidence of any active and uncontrolled bacterial or viral infection.
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
History of human immunodeficiency virus infection, hepatitis B, or hepatitis C; positive testing for human immunodeficiency virus, Hepatitis B surface antigen, Hepatitis B core antibody or hepatitis C virus antibody. Hepatitis B vaccination is allowed.
Positive COVID-19 test at first admission.
Other medical or psychiatric conditions, laboratory test abnormalities, other conditions or situations related to COVID-19 pandemic or, in the investigator's judgment, make the participant inappropriate 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
Encorafenib capsule formulation (CAP)A single encorafenib dose of the CAP formulation	Drug	Four Period Treatment Sequence: PPI Effect, Four Period Treatment Sequence: PPI Effect Second Formulation
Encorafenib first formulationfirst formulation	Drug	Four Period Treatment Sequence: PPI Effect, Four Period Treatment Sequence: PPI Effect Second Formulation
Encorafenib second formulationsecond formulation	Drug	Four Period Treatment Sequence: PPI Effect, Four Period Treatment Sequence: PPI Effect Second Formulation
Rabeprazole tabletProton-pump inhibitor	Drug	Four Period Treatment Sequence: PPI Effect, Four Period Treatment Sequence: PPI Effect Second Formulation

Primary outcome

Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
AUCinf for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by AUClast + (Clast/kel), where AUClast was the area under the plasma concentration-time profile from time zero to last quantifiable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was first-order elimination rate constant.
Maximum Observed Plasma Concentration (Cmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Cmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data.
Area Under the Plasma Concentration-Time Profile From Time Zero to Last Quantifiable Concentration (AUClast) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
AUClast for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated using Linear/Log trapezoidal method.

8 secondary outcomes

Time for Cmax (Tmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Terminal Half-Life (t½) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Apparent Clearance (CL/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Apparent Volume of Distribution (Vz/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 28 after the last encorafenib dose (the total duration of the study was approximately 60 days from baseline)
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Time frame: Baseline, and at early discontinuation or at the discretion of the investigator (the total duration of the study was approximately 60 days from baseline)
Number of Participants Meeting Vital Signs Categorical Criteria
Time frame: Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)
Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)

Results and safety

Results posted to the registry on 23 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Encorafenib 75 mg eMCC=>75 mg eMCCL=>75 mg CAP=>75 mg eMCC+20 mg Rabeprazole	3	3
Encorafenib 75 mg eMCC=>75 mg CAP=>75 mg eMCCL=>75 mg eMCCL+20 mg Rabeprazole	3	3
Encorafenib 75 mg eMCCL=>75 mg CAP=>75 mg eMCC=>75 mg eMCC+20 mg Rabeprazole	3	3
Encorafenib 75 mg eMCCL=>75 m eMCC=>75 mg CAP=>75 mg eMCCL+20 mg Rabeprazole	3	3
Encorafenib 75 mg CAP=>75 mg eMCC=>75 mg eMCCL=>75 mg eMCC+20 mg Rabeprazole	3	3
Encorafenib 75 mg CAP=>75 mg eMCCL=>75 mg eMCC=>75 mg eMCCL+20 mg Rabeprazole	3	3

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole

Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	75 mg Encorafenib eMCC, Fasted n = 18	75mg Encorafenib eMCCL, Fasted n = 17	75mg Encorafenib CAP, Fasted n = 17	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted n = 7	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted n = 9
Value	2895 (44)	2909 (49)	2957 (41)	2825 (35)	2556 (63)

75 mg Encorafenib eMCC, Fasted vs 75mg Encorafenib CAP, Fasted: Reference/Test Ratio: 95.25 (90% CI 90.82 to 99.90)
75mg Encorafenib eMCCL, Fasted vs 75mg Encorafenib CAP, Fasted: Reference/Test Ratio: 96.30 (90% CI 91.71 to 101.12)
75 mg Encorafenib eMCC, Fasted vs 75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted: Reference/Test Ratio: 96.57 (90% CI 82.91 to 112.47)

Population analysed: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole

Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	75 mg Encorafenib eMCC, Fasted n = 18	75mg Encorafenib eMCCL, Fasted n = 18	75mg Encorafenib CAP, Fasted n = 17	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted n = 8	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted n = 9
Value	898.4 (46)	778.2 (45)	845.8 (36)	686.0 (43)	631.7 (70)

75 mg Encorafenib eMCC, Fasted vs 75mg Encorafenib CAP, Fasted: Reference/Test Ratio: 104.31 (90% CI 91.40 to 119.04)
75mg Encorafenib eMCCL, Fasted vs 75mg Encorafenib CAP, Fasted: Reference/Test Ratio: 90.35 (90% CI 79.17 to 103.12)
75 mg Encorafenib eMCC, Fasted vs 75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted: Reference/Test Ratio: 79.66 (90% CI 58.70 to 108.08)

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time Zero to Last Quantifiable Concentration (AUClast) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole

Time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	75 mg Encorafenib eMCC, Fasted n = 18	75mg Encorafenib eMCCL, Fasted n = 18	75mg Encorafenib CAP, Fasted n = 17	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted n = 8	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted n = 9
Value	2879 (44)	2858 (48)	2934 (41)	2635 (37)	2529 (65)

75 mg Encorafenib eMCC, Fasted vs 75mg Encorafenib CAP, Fasted: Reference/Test Ratio: 95.34 (90% CI 90.37 to 100.59)
75mg Encorafenib eMCCL, Fasted vs 75mg Encorafenib CAP, Fasted: Reference/Test Ratio: 94.67 (90% CI 89.73 to 99.88)
75 mg Encorafenib eMCC, Fasted vs 75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted: Reference/Test Ratio: 95.76 (90% CI 84.10 to 109.04)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
75 mg Encorafenib eMCC, Fasted	0 of 18 (0%)	11 of 18 (61.1%)	0 of 18
75 mg Encorafenib eMCCL, Fasted	0 of 18 (0%)	11 of 18 (61.1%)	0 of 18
75 mg Encorafenib CAP, Fasted	0 of 17 (0%)	8 of 17 (47.1%)	0 of 17
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

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 Encorafenib capsule formulation (CAP), Encorafenib first formulation and Encorafenib second formulation in people with Healthy, run by Pfizer 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 5 inclusion and 15 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 23 Feb 2024. 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 23 Feb 2024). 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?

Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole (time frame: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05446142.

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 23 Feb 2024.