NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations
A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations

NCT05446142

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