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

Akcea Therapeutics16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

ISIS 681257DRUG

Xmg dose administered as a subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Clinical Site

Orlando, Florida, United States

Clinical Site

Knoxville, Tennessee, United States

Clinical Site

Québec, Canada

Outcomes

Primary Outcomes

Evaluate the effect of ISIS 681257 following a single subcutaneous dose in subjects with impaired renal function relative to matched, healthy controls with normal renal function.

The plasma concentrations of ISIS 681257 will be measured.

Time frame: Day 31

Secondary Outcomes

The incidence of adverse effects of ISIS 681257 in subjects with normal and impaired renal function.

The safety of ISIS 681257 will be assessed by determining adverse effects by dose. Safety results in subjects with renal impairment dosed with ISIS 681257 will be compared with those from healthy subjects dosed with ISIS 681257.

Time frame: Day 31

The plasma protein binding of ISIS 681257 in subjects with normal and impaired renal function.

Percent of ISIS 681257 bound to proteins in subjects with renal impairment dosed with ISIS 681257 will be compared with those from healthy subjects dosed with ISIS 681257.

Time frame: Day 1

Data from ClinicalTrials.gov

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