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A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations
A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations
CompletedPhase 1
Sponsor: Pfizer
Conditions: Healthy
Interventions: Encorafenib capsule formulation (CAP), Encorafenib first formulation, Encorafenib second formulation, Rabeprazole tablet
Countries: United States
Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility 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
Locations (1)
- New Haven, Connecticut, United States