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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506854
• Other study ID #: ISIS 681257-CS12
• Status: Completed
• Phase: Phase 1
• Start date: March 20, 2018
• Est. completion date: October 11, 2018

Study information

• Verified date: May 2019
• Source: Akcea Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• ISIS 681257
Xmg dose administered as a subcutaneous injection

Locations

Country	Name	City	State
Canada	Clinical Site	Québec
United States	Clinical Site	Knoxville	Tennessee
United States	Clinical Site	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Akcea Therapeutics	Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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