Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects

Exclusion Criteria

• •Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days prior to the first dose of study drug.
• •History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
• •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (eg, proton-pump inhibitors \[PPIs\]).
• •Women who are pregnant or lactating. Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
• •Unable to refrain from or anticipates the use of:
• •Any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements (including proton-pump inhibitors) beginning 14 days prior to the first dose of study drug and throughout the study. Acetaminophen (up to 2 g per 24 hour period) and/or loperamide (up to 6 mg per 24 hours) may be permitted during the study at the direction of the PI.
• •Any drugs known to be significant inducers of cytochrome p450 enzymes and/or P glycoprotein, including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/pharmacodynamics interaction with study drug.