Dexpramipexole Renal PK Study

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424176
• Other study ID #: 223RI101
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2011
• Last updated: November 24, 2014
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2014
• Source: Knopp Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Renal Insufficiency

Intervention

Drug:
• Dexpramipexole (dose 1)

• Dexpramipexole (dose 2)

Locations

Country	Name	City	State
United States	Research Site	Brooklyn Center	Minnesota
United States	Research Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Knopp Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC after single dose of dexpramipexole		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.	No
Primary	Cmax after single dose of dexpramipexole		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.	No
Secondary	Mointoring of Clinical Laboratory tests		pre-144 hours post dose	Yes
Secondary	ECG Monitoring		pre-144 hrs post dose	Yes
Secondary	Vital Sign monitoring		pre-144 hrs post dose	Yes
Secondary	AE monitoring		pre-144 hrs post dose	Yes