A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib

Inclusion criteria

• Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator.
• Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at Screening and Check-in. Females of childbearing potential must agree to use contraception.
• Male subjects must agree to use contraception.
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Exclusion criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, thrombotic, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the investigational product (IP), or other substance (not including seasonal allergies).
• History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome).
• Significant history or clinical manifestation of any hepatic disease, as determined by laboratory abnormalities.
• History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.
• Ventricular dysfunction or history of risk factors for Torsades de Pointes.
• History of drug abuse within 2 years prior to Screening.
• History of alcohol abuse within 12 months prior to Screening.
• Positive serology test results for hepatitis B surface antigen, hepatitis C antibody, and/or human immunodeficiency virus (HIV) 1/2.
• Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
• Use of any drugs or substances known or suspected to alter drug absorption, distribution, metabolism, or elimination.
• Use or intend to use any prescription medications/products within 14 days prior to Check-in.
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days.
• Subjects who, in the opinion of the Investigator, should not participate in this study.