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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03506854

Enrollment

Registered

2018-04-24

Start date

2018-03-20

Completion date

2018-10-11

Last updated

2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

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

Interventions

DRUGISIS 681257

Xmg dose administered as a subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026