Dexpramipexole Renal PK Study

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01424176
First received: June 23, 2011
Last updated: June 7, 2012
Last verified: January 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mointoring of Clinical Laboratory tests [ Time Frame: pre-144 hours post dose ] [ Designated as safety issue: Yes ]
  • ECG Monitoring [ Time Frame: pre-144 hrs post dose ] [ Designated as safety issue: Yes ]
  • Vital Sign monitoring [ Time Frame: pre-144 hrs post dose ] [ Designated as safety issue: Yes ]
  • AE monitoring [ Time Frame: pre-144 hrs post dose ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexpramipexole (dose 1) Drug: Dexpramipexole (dose 1)
Other Name: BIIB050
Experimental: Dexpramipexole (dose 2) Drug: Dexpramipexole (dose 2)
Other Name: BIIB050

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT01424176     History of Changes
Other Study ID Numbers: 223RI101
Study First Received: June 23, 2011
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014