Status:
COMPLETED
Dexpramipexole Renal PK Study
Lead Sponsor:
Knopp Biosciences
Conditions:
Amyotrophic Lateral Sclerosis
Renal Insufficiency
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01424176
Start Date
July 1 2011
End Date
January 1 2012
Last Update
November 25 2014
Active Locations (2)
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1
Research Site
Orlando, Florida, United States, 32809
2
Research Site
Brooklyn Center, Minnesota, United States, 55430