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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-10-11

Brief Summary

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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

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ISIS 681257

Intervention Type DRUG

Xmg dose administered as a subcutaneous injection

Moderate Renal Impairment

Presence of moderate renal impairment (eGFR 30-59 mL/min/1.73m2). Subjects will receive 1 dose of ISIS 681257.

Group Type EXPERIMENTAL

ISIS 681257

Intervention Type DRUG

Xmg dose administered as a subcutaneous injection

Interventions

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ISIS 681257

Xmg dose administered as a subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes