A Single-Dose, PK/PD, & Safety Study of BIIB017 in Subjects With Renal Impairment & Healthy Volunteers - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy Renal Insufficiency	Drug: PEG IFN	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Pharmacokinetics: AUC, Cmax, Tmax, t1/2, Cl/F, Vd/F [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: vital signs, ECGs, AEs, Clinical Laboratory tests [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	35
Study Start Date:	May 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PEG IFN Renal Impaired Subjects and Healthy Volunteers	Drug: PEG IFN single dose of 63 or 125 mcg

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119781

Locations

United States, Florida
Research Site
Orlando, Florida, United States
United States, Minnesota
Research Site
St. Paul, Minnesota, United States
United States, Tennessee
Research Site
Knoxville, Tennessee, United States

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec Medical Director, Biogen Idec, Inc.
ClinicalTrials.gov Identifier:	NCT01119781 History of Changes
Other Study ID Numbers:	105RI101
Study First Received:	May 6, 2010
Last Updated:	June 14, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013