Clinical trial NCT01119781: A Single-Dose, Pharmacokinetic/Pharmacodynamic (PK/PD), & Safety Study of BIIB017 in Participants With Renal Impairment & Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Renal Insufficiency
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the time-concentration curve (AUC) for serum concentrations of peginterferon beta-1a
timeFrame: 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 outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Day 1 up to Week 5
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hu X, Seddighzadeh A, Stecher S, Zhu Y, Goyal J, Matson M, Marbury T, Smith W, Nestorov I, Hung S. Pharmacokinetics, pharmacodynamics, and safety of peginterferon beta-1a in subjects with normal or impaired renal function. J Clin Pharmacol. 2015 Feb;55(2):179-88. doi: 10.1002/jcph.390. Epub 2014 Sep 23.