Dexpramipexole Renal PK Study
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01424176
First received: June 23, 2011
Last updated: June 7, 2012
Last verified: January 2012
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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:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
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 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 May 16, 2013