Dexpramipexole Renal PK Study
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|ClinicalTrials.gov Identifier: NCT01424176|
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : November 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis Renal Insufficiency||Drug: Dexpramipexole (dose 1) Drug: Dexpramipexole (dose 2)||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal Impairment|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Dexpramipexole (dose 1)
Subjects with mild or moderate renal impairment.
Drug: Dexpramipexole (dose 1)
Other Name: BIIB050
Experimental: Dexpramipexole (dose 2)
Subjects with severe renal impairment and end stage renal disease (ESRD).
Drug: Dexpramipexole (dose 2)
Other Name: BIIB050
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424176
|United States, Florida|
|Orlando, Florida, United States, 32809|
|United States, Minnesota|
|Brooklyn Center, Minnesota, United States, 55430|