This is a multicenter, open-label, single-dose, PK and safety study in subjects with various stages of renal impairment.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Research Site
Orlando, Florida, United States
Research Site
Brooklyn Center, Minnesota, United States
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.
Cmax 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.
Mointoring of Clinical Laboratory tests
Time frame: pre-144 hours post dose
ECG Monitoring
Time frame: pre-144 hrs post dose
Vital Sign monitoring
Time frame: pre-144 hrs post dose
AE monitoring
Time frame: pre-144 hrs post dose
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