A Single-Dose, PK/PD, & Safety Study of BIIB017 in Subjects With Renal Impairment & Healthy Volunteers - NCT01119781-(Clinical Trial 700064)
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Knoxville |
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State:
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TN |
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| Conditions: |
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Healthy - Renal Insufficiency |
| Purpose: |
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This is an open-label, multicenter, non-randomized, serial-group, pharmacokinetic (PK), PD,
and safety study in healthy subjects, and in subjects with renal impairment
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| Study summary: |
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This study is an open-label, multicenter, non-randomized, serial-group study to estimate the
effect of renal impairment on BIIB017 PK/PD. The study will be conducted at approximately 3
sites in the US and will enroll approximately 35 subjects (6 subjects per Groups 1, 3, and
5; 9 subjects in Group 2; and 8 subjects in Group 4) who will participate in the study for
approximately 9 weeks (including screening, treatment, PK/PD sample collection, and a
follow-up visit). Subjects who prematurely withdraw from the study prior to receiving
BIIB017 will be replaced. |
| Criteria: |
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Inclusion Criteria:
- Subjects must have stable renal disease (i.e., no change in disease status within the
last month) as determined by the Investigator with laboratory and clinical findings
that support the diagnosis of renal impairment.
- Aged 18 to 75 years old, inclusive, at the time of informed consent.
- Must have body mass index (BMI) between 18 and 35 kg/m2 inclusive.
Exclusion Criteria:
- History of any clinically unstable (in the past 6 months prior to screening) cardiac,
endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,
neurologic, dermatologic, and psychiatric, or other major disease as determined by
the Investigator.
- Any evidence of clinically significant findings on screening evaluations, which, in
the opinion of the Investigator would pose a safety risk, or would interfere with
appropriate interpretation of safety or PK data, or other unspecified reasons that,
in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for
enrollment |
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| Study is available at: |
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Research Site
Knoxville, TN
United States
Primary Contact:
Medical Director
Email: neurologyclinicaltrials@biogenidec.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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