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

Biogen

Status and phase

Completed

Phase 1

Conditions

Healthy

Renal Insufficiency

Treatments

Drug: BIIB017(peginterferon beta-1a)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01119781

105RI101

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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