BG9928 in Subjects With Hepatic Impairment

NCT ID: NCT00858156

Last Updated: 2010-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

Brief Summary

The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic function.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

BG9928

Oral 75 mg single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must be between the ages of 18 and 75, inclusive.
• Must have a Body Mass Index (BMI) between 19 kg/m2 and 36 kg/m2, inclusive.

The following criteria apply only to subjects enrolled into Groups 1 and 2 (mild or moderate hepatic impairment):

• Must have stable hepatic disease (i.e., no change in disease status within the last 2 months as determined by the enrolling Investigator) with laboratory and clinical findings that support the diagnosis of hepatic impairment.
• Must have a total Child-Pugh score (Section 22, Appendix I) of 5-6 (mild), or 7-9 (moderate).
• Must be otherwise healthy as determined by the Investigator on the basis of pre-study physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters. Subjects with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. Subjects with stable, mild, chronic concurrent diseases, such as degenerative joint disease, may be included.

Exclusion Criteria

• History of an allergic reaction to any methylxanthine-containing compound.
• History of seizure within the past 10 years, or use of any medication for the suppression of seizures within the past 5 years.
• History of brain surgery, meningitis/encephalitis, penetrating head trauma, stroke, or transient ischemic attack within the past 6 months.
• History of active (within 6 months) drug or alcohol abuse, a positive drug screen (without a medically indicated rationale), or a positive alcohol breath test at Screening or on Day -2.
• History of Human Immunodeficiency Virus (HIV) antibody.
• Serious systemic infection (e.g., septicemia) within the 30 days prior to Day 1.
• Fever, with body temperature >38oC, within the 48 hours prior to Day 1.
• Active bacterial or viral infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Biogen Idec, Inc

Principal Investigators

Biogen Idec

Role: STUDY_DIRECTOR

Biogen

Locations

Miami, Florida, United States

Orlando, Florida, United States

Countries

United States

Other Identifiers

161HI101

Identifier Type: -

Identifier Source: org_study_id