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

• Status: Completed
• Trial end date: 2018-10-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akcea Therapeutics
• Collaborator: Ionis Pharmaceuticals, Inc.

Criteria

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