A Single-Dose, PK/PD, & Safety Study of BIIB017 in Subjects With Renal Impairment & Healthy Volunteers
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2010 |
| End Date: | November 2010 |
An Open-Label, Single-dose, Pharmacokinetic, Pharmacodynamic, and Safety Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Subjects and Subjects With Renal Impairment
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
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.
We found this trial at
3
sites
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