Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

A Randomized, Open-Label, Single-Dose, Three-Period Crossover Study in Healthy Adults to Assess the Relative Bioavailability of Test and Reference Formulations of AKB-6548 Tablets and to Evaluate the Effect of Food on the Bioavailability of AKB-6548

The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.

Inclusion Criteria:

• Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive.

Exclusion Criteria:

• Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
• Positive serology results for HBsAg, HCV, and HIV at Screening.
• Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/min
• Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months.
• Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
• Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.