Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 10/19/2013 |
Start Date: | August 2013 |
End Date: | March 2014 |
Contact: | Cheryl Chen |
Email: | cechen@neurocrine.com |
Phone: | 858-617-7744 |
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild, Moderate, or Severe Hepatic Insufficiency
The purpose of this research study is to: test the safety, tolerability, and
pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down
and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in
subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.
Inclusion Criteria:
- Male or female, 18 to 75 years of age.
- Healthy volunteers must be in good general health.
- Subjects with hepatic impairment must be judged to be in stable condition.
- Subjects of childbearing potential must agree to use hormonal or two forms of
nonhormonal birth control during the study.
- Female subjects must not be pregnant, given birth within 1 year of study start, or
breastfeeding.
- Have a body mass index (BMI) of 18 to 40 kg/m2 (both inclusive).
Exclusion Criteria:
- Report more than two alcoholic beverages daily or more than 14 alcoholic beverages
weekly withing 7 days of study start.
- Have a known history of neuroleptic malignant syndrome.
- Have a positive human immunodeficiency virus (HIV) antibody result at screening or
have a history of positive result.
- Have received an investigational drug within 30 days before screening or plan to use
an investigational drug (other than NBI-98854) during the study.
- Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- Had a blood loss greater than or equal to 500 mL or donated blood within 56 days of
study start.
- Have had previous exposure with NBI-98854.
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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