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

Akcea Therapeutics

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: ISIS 681257

Study type: Interventional

Funder types: Industry

Identifiers

NCT03506854

ISIS 681257-CS12

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Normal Renal Function

Experimental group

Description:

Subjects with normal renal function will be matched by age (±10 years), weight (± 20%), and gender to the pooled mean values of subjects with the moderate renal impairment. Subjects will receive 1 dose of ISIS 681257.

Treatment:

Drug: ISIS 681257

Moderate Renal Impairment

Experimental group

Description:

Presence of moderate renal impairment (eGFR 30-59 mL/min/1.73m2). Subjects will receive 1 dose of ISIS 681257.

Treatment:

Drug: ISIS 681257