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

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: ISIS 681257

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, H7V4B3
    • Clinical Site
• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Clinical Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Normal Renal Function; 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.	Drug: ISIS 681257; Xmg dose administered as a subcutaneous injection
EXPERIMENTAL: Moderate Renal Impairment; Presence of moderate renal impairment (eGFR 30-59 mL/min/1.73m2). Subjects will receive 1 dose of ISIS 681257.	Drug: ISIS 681257; Xmg dose administered as a subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 1

Collaborators and Investigators

• Sponsor: Akcea Therapeutics
• Collaborators: Ionis Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2018
• Primary Completion (ACTUAL): October 11, 2018
• Study Completion (ACTUAL): October 11, 2018

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (ACTUAL): April 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: ISIS 681257-CS12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No