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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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

Key facts

Study ID

NCT03506854

Run by

Akcea Therapeutics

People needed

16

Starts

2018-03-20

Expected to finish

2018-10-11

Last updated by the study team

2019-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Clinical Site — Orlando, Florida, United States
• Clinical Site — Knoxville, Tennessee, United States
• Clinical Site — Québec, Canada

Full record on ClinicalTrials.gov

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