BG9928 in Subjects With Hepatic Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858156
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : January 27, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: BG9928 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Intervention Details:
  • Drug: BG9928
    Oral 75 mg single dose

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00858156

United States, Florida
Miami, Florida, United States, 33014
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Study Director: Biogen Idec Biogen

Responsible Party: Biogen Idec, Medical Director, Biogen Idec, Inc Identifier: NCT00858156     History of Changes
Other Study ID Numbers: 161HI101
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: January 2010

Keywords provided by Biogen:

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases