Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients

Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study Of ISIS 681257 Subcutaneous Injections In Male And Female Subjects With Normal And Impaired Renal Function

This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and Impaired Renal Function

Inclusion Criteria:

• At least 18 years old
• BMI 18.5 to 42.0 kg/m2
• No known diseases or significant findings on physical exam (normal renal only)
• eGFR >/= 90 mL/min/1.73m2 (normal renal only)
• Clinically stable (renal impaired only)
• eGFR 30-59 mL/min/1.73m2 (renal impaired only)

Exclusion Criteria:

• Females of childbearing potential
• Conditions or disease that may interfere with study drug
• Any significant diseases
• Hypersensitivity to any drugs or similar drugs to those used in the study
• Drug dependency or abuse
• Previous exposure to other investigational drug within 28 days
• Blood donations within 28 days