A Single-Dose, Pharmacokinetic/Pharmacodynamic (PK/PD), & Safety Study of BIIB017 in Participants With Renal Impairment & Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119781
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : June 2, 2014
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Brief Summary:
The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of PEGylated Interferon Beta-1a (BIIB017) administered subcutaneous in participants with renal impairment and in participants with normal renal function (healthy participants). A secondary objective of this study in this study population is to evaluate the safety and tolerability of a single dose of PEGylated Interferon Beta-1a administered subcutaneous.

Condition or disease Intervention/treatment Phase
Healthy Renal Insufficiency Drug: BIIB017(peginterferon beta-1a) Phase 1

Detailed Description:
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 participants: 6 healthy volunteers (normal renal function), 9 with mild renal impairment, 6 with moderate renal impairment, 8 with severe renal impairment, and 6 participants with end stage renal disease who require hemodialysis 2 to 3 times a week.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Single-dose, Pharmacokinetic, Pharmacodynamic, and Safety Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Subjects and Subjects With Renal Impairment
Study Start Date : May 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: peginterferon beta-1a
Single dose of peginterferon beta-1a at either 63 or 125 mcg in renal impaired Participants and healthy volunteers
Drug: BIIB017(peginterferon beta-1a)
peginterferon beta-1a administered by a single subcutaneous (SC) injection using a pre-filled syringe on Day 1 at a dose of either 63 or 125 mcg depending on subpopulation assignment reflecting whether a healthy volunteer or level of renal impairment.

Primary Outcome Measures :
  1. Area under the time-concentration curve (AUC) for serum concentrations of peginterferon beta-1a [ Time Frame: Post-hemodialysis, pre-dose on Day 1, post dose at 6, 12, 24, 36, 48, 72, 96, 168, 240, 336, 408, 504, 576 and 672 hours ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1 up to Week 5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Key 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.
  • Must have body mass index (BMI) between 18 and 35 kg/m2 inclusive.

Key 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

NOTE: Other protocol defined Inclusion/Exclusion Criteria May Apply

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 identifier (NCT number): NCT01119781

Sponsors and Collaborators
Study Director: Medical Director Biogen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Biogen Identifier: NCT01119781     History of Changes
Other Study ID Numbers: 105RI101
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs