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Dexpramipexole Renal PK Study

Primary Purpose

Amyotrophic Lateral Sclerosis, Renal Insufficiency

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dexpramipexole (dose 1)

Dexpramipexole (dose 2)

About this trial

This is an interventional basic science trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult males/females aged 18 to 75 years inclusive and between 19 and 36 kg/m2 inclusive BMI.
Subjects with renal impairment must have stable renal disease (i.e., no change in disease status within the 28 days prior to dosing) as determined by the Investigator with laboratory and clinical findings that support the diagnosis of renal impairment.
Subjects with renal impairment (excluding ESRD subjects), must have 2 separate estimates of creatinine clearance that are within 25% of each other, obtained >5 days apart, but not >6 months apart
Subjects must have a GFR (estimated GFR; as defined by estimation of creatinine clearance using the MDRD formula) of ≥80 (healthy volunteers), between 50 and 79 (mild renal impairment), between 30 and 49 (moderate renal impairment), or <30 (severe renal impairment), or must require dialysis ≤3 times a week (ESRD).
Healthy volunteers must be matched to renally impaired subjects for age (± 10 years), gender, and if possible BMI (± 20%).

Exclusion Criteria:

Healthy volunteers who have received prescription medication within the 14 days prior to dosing (except for birth control).
Renally impaired subjects who have received prescription medication within the 14 days prior to dosing (except for birth control and medications taken at a stable dose for underlying conditions, as determined by the Investigator).

Sites / Locations

Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dexpramipexole (dose 1)

Dexpramipexole (dose 2)

Arm Description

Subjects with mild or moderate renal impairment.

Subjects with severe renal impairment and end stage renal disease (ESRD).

Outcomes

Primary Outcome Measures

AUC after single dose of dexpramipexole

Cmax after single dose of dexpramipexole

Secondary Outcome Measures

Mointoring of Clinical Laboratory tests

ECG Monitoring

Vital Sign monitoring

AE monitoring

Full Information

NCT ID

NCT01424176

First Posted

June 23, 2011

Last Updated

November 24, 2014

Sponsor

Knopp Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT01424176

Brief Title

Dexpramipexole Renal PK Study

Official Title

A Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Knopp Biosciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multicenter, open-label, single-dose, PK and safety study in subjects with various stages of renal impairment.

Detailed Description

Dexpramipexole (BIIB050, KNS-760704; (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate) is a synthetic amino-benzothiazole. Data from multiple in vitro and in vivo assays have suggested that dexpramipexole is neuroprotective. It is being investigated for the treatment ALS. As dexpramipexole is principally eliminated from the body by the kidneys a single oral dose of dexpramipexole will be administered to subjects with various stages of renal impariment comprising the following categories: mild, moderate, severe and ESRD subjects. Healthy volunteers will be matched to each catergory of renal impaired subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis, Renal Insufficiency

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexpramipexole (dose 1)

Arm Type

Experimental

Arm Description

Subjects with mild or moderate renal impairment.

Arm Title

Dexpramipexole (dose 2)

Arm Type

Experimental

Arm Description

Subjects with severe renal impairment and end stage renal disease (ESRD).

Intervention Type

Drug

Intervention Name(s)

Dexpramipexole (dose 1)

Other Intervention Name(s)

BIIB050

Intervention Type

Drug

Intervention Name(s)

Dexpramipexole (dose 2)

Other Intervention Name(s)

BIIB050

Primary Outcome Measure Information:

Title

AUC after single dose of dexpramipexole

Time Frame

pre dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing in all subjects, and in addition at 96, 120, and 144 hours after dosing in subjects with severe renal impairment and ESRD.

Title

Cmax after single dose of dexpramipexole

Time Frame

Secondary Outcome Measure Information:

Title

Mointoring of Clinical Laboratory tests

Time Frame

pre-144 hours post dose

Title

ECG Monitoring

Time Frame

pre-144 hrs post dose

Title

Vital Sign monitoring

Time Frame

pre-144 hrs post dose

Title

AE monitoring

Time Frame

pre-144 hrs post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult males/females aged 18 to 75 years inclusive and between 19 and 36 kg/m2 inclusive BMI. Subjects with renal impairment must have stable renal disease (i.e., no change in disease status within the 28 days prior to dosing) as determined by the Investigator with laboratory and clinical findings that support the diagnosis of renal impairment. Subjects with renal impairment (excluding ESRD subjects), must have 2 separate estimates of creatinine clearance that are within 25% of each other, obtained >5 days apart, but not >6 months apart Subjects must have a GFR (estimated GFR; as defined by estimation of creatinine clearance using the MDRD formula) of ≥80 (healthy volunteers), between 50 and 79 (mild renal impairment), between 30 and 49 (moderate renal impairment), or <30 (severe renal impairment), or must require dialysis ≤3 times a week (ESRD). Healthy volunteers must be matched to renally impaired subjects for age (± 10 years), gender, and if possible BMI (± 20%). Exclusion Criteria: Healthy volunteers who have received prescription medication within the 14 days prior to dosing (except for birth control). Renally impaired subjects who have received prescription medication within the 14 days prior to dosing (except for birth control and medications taken at a stable dose for underlying conditions, as determined by the Investigator).

Facility Information:

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Research Site

City

Brooklyn Center

State/Province

Minnesota

ZIP/Postal Code

55430

Country

United States

12. IPD Sharing Statement

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Dexpramipexole Renal PK Study

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