A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT05446142

Run by

Pfizer

People needed

18

Starts

2022-07-01

Expected to finish

2022-09-30

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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