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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
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Renal Insufficiency Drug: Dexpramipexole (dose 1) Drug: Dexpramipexole (dose 2) Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]
  2. 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. ]

Secondary Outcome Measures :
  1. Mointoring of Clinical Laboratory tests [ Time Frame: pre-144 hours post dose ]
  2. ECG Monitoring [ Time Frame: pre-144 hrs post dose ]
  3. Vital Sign monitoring [ Time Frame: pre-144 hrs post dose ]
  4. AE monitoring [ Time Frame: pre-144 hrs post dose ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Locations
United States, Florida
Research Site
Orlando, Florida, United States, 32809
United States, Minnesota
Research Site
Brooklyn Center, Minnesota, United States, 55430
Sponsors and Collaborators
Knopp Biosciences

Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01424176     History of Changes
Other Study ID Numbers: 223RI101
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Renal Insufficiency
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents