Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment

Exclusion Criteria

• •Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
• •Known or suspected malignancy;
• •Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
• •Positive pregnancy test result.
• •Severe uncontrolled hypertension (diastolic \> 115 mmHg or systolic blood pressure \> 180 mmHg) at either the Screening visit or the Study Check-in Visit;
• •Type I diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1c \> 10%) at the Screening visit;
• •Prior kidney transplant, or anticipated need for transplant during study participation;
• •Clinical diagnosis of heart failure and persistent symptoms (New York Heart Association \[NYHA\] Class II- IV) at either the Screening visit or the Study Check-in Visit;
• •Known or suspected contraindications to study medications, including history of hypersensitivity or allergy to ACE inhibitors, ARBs, or aldosterone antagonists;
• •Any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history, which in the investigators opinion could interfere with the results of the trial;
• •Diabetic gastroparesis;
• •Known bilateral clinically relevant renal artery stenosis (\>75% reduction in artery diameter).