Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects

Inclusion criteria

• Males or females, of any race, 18 to 65 years of age, inclusive, at Screening.
• Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening.
• In good health.
• Females will be nonpregnant and nonlactating, and females of childbearing potential and males will 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, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
• Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose.
• Females of childbearing potential who are pregnant or lactating. Females of non-childbearing potential are defined as permanently sterile or postmenopausal. Postmenopausal status will be confirmed with a screening serum follicle-stimulating hormone (FSH) level greater than 40 mIU/mL.
• A history or evidence of clinically significant gastrointestinal disease, including ulcers, gastro-esophageal reflux disease, or gastritis.
• A history of alcoholism or drug/chemical abuse within 2 years prior to Period 1 Check-in.
• Regular alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
• Positive urine drug screen (confirmed by repeat) at Screening (does not include alcohol) or Check-in (does include alcohol).
• Use of prescription or nonprescription drugs, including vitamins, herbal, and dietary supplements (ie, St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of IMP.
• Use of tobacco, smoking cessation products, or products containing nicotine (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum) within 6 months prior to Period 1 Check-in until Discharge from the CRU following the final dose.
• Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges will not be allowed from 7 days prior to Period 1 Check-in until Discharge from the CRU following the final dose.
• Consumption of caffeine-containing foods and beverages will not be allowed from 72 hours prior to Check-in until Discharge on Day 4 of each treatment period.
• Poor peripheral venous access.
• Evidence of renal impairment at Screening, as indicated by an estimated creatinine clearance of less than 80 mL/min using the Cockcroft-Gault equation.
• Screening chemistry laboratory values as follows: gamma-glutamyltransferase, aspartate aminotransferase, and ALT >1.5 × institutional upper limit of normal (ULN), total bilirubin >1.5 × institutional ULN.
• A history of seizures (not including simple febrile seizures in childhood);
• Multiple drug allergies or allergies to any of the components of CPI-444 tablets or CPI 444 resinate capsules.
• Known history of human immunodeficiency virus or active infection requiring therapy, or positive tests for hepatitis B surface antigen or hepatitis C antibody.
• Any vaccination against infectious diseases (ie, influenza, varicella) within 28 days of first dose.
• Donation or loss of greater than 400 mL of blood from 2 months prior to Screening, donation of platelets from 6 weeks prior to Screening, or plasma from 2 weeks prior to Screening through the Follow-up phone call.
• Receipt of blood products within 2 months prior to Period 1 Check-in.
• Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.