A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations

• Status: Not yet recruiting
• Trial end date: 2022-09-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Collaborators: Ono Pharmaceutical Co. Ltd; Pierre Fabre Laboratories
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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