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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: ISIS 681257

• Registration Number: NCT03506854
• Lead Sponsor: Akcea Therapeutics

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-20
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-04-24
• Primary Completion: 2018-10-11
• Study Completion: 2018-10-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Moderate Renal Impairment	ISIS 681257	Presence of moderate renal impairment (eGFR 30-59 mL/min/1.73m2). Subjects will receive 1 dose of ISIS 681257.
Normal Renal Function	ISIS 681257	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.

Primary Outcome Measures

Name	Time	Method
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.	Day 31	The plasma concentrations of ISIS 681257 will be measured.

Secondary Outcome Measures

Name	Time	Method
The plasma protein binding of ISIS 681257 in subjects with normal and impaired renal function.	Day 1	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.
The incidence of adverse effects of ISIS 681257 in subjects with normal and impaired renal function.	Day 31	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.

Trial Locations

Locations (1)

Clinical Site; 🇨🇦 Québec, Canada