Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 singl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01916993
Start Date
August 1 2013
End Date
December 1 2013
Last Update
January 16 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
DaVita Clinical Research
Lakewood, Colorado, United States, 80228
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404