Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Completed · Phase 1
Conditions studied: Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
In brief
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.
Key facts
- Study ID
- NCT01916993
- Run by
- Neurocrine Biosciences
- People needed
- 24
- Starts
- 2013-08-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2014-01-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- DaVita Clinical Research — Lakewood, Colorado, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- Davita Clinical Research — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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