Clinical trial NCT00858156: BG9928 in Subjects With Hepatic Impairment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Pharmacokinetics
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.


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.

Primary outcomes:
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
timeFrame: 1 week post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
Study officials:
affiliation: Biogen
name: Biogen Idec
role: STUDY_DIRECTOR
References: