Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neurocrine Biosciences

Criteria

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.