BG9928 in Subjects With Hepatic Impairment

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858156
• Other study ID #: 161HI101
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2009
• Last updated: January 26, 2010
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: January 2010
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• BG9928
Oral 75 mg single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 week post dose	Yes