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BG9928 in Subjects With Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT00858156
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : January 27, 2010
Sponsor:
Information provided by:
Biogen

March 5, 2009
March 9, 2009
January 27, 2010
April 2009
August 2009   (Final data collection date for primary outcome measure)
The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic function [ Time Frame: 1 week post dose ]
Same as current
Complete list of historical versions of study NCT00858156 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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BG9928 in Subjects With Hepatic Impairment
An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Oral BG9928 in Subjects With Mild and Moderate Hepatic Impairment and in Healthy Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Hepatic Impairment
Drug: BG9928
Oral 75 mg single dose
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
28
August 2009
August 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00858156
161HI101
No
Not Provided
Not Provided
Biogen Idec, Medical Director, Biogen Idec, Inc
Biogen
Not Provided
Study Director: Biogen Idec Biogen
Biogen
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP