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

Neurocrine Biosciences

Status and phase: Completed; Phase 1

Conditions: Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects

Treatments: Drug: NBI-98854 50 mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01916993

NBI-98854-1303

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Healthy Volunteers

Experimental group

Description:

single dose of NBI-98854 50 mg capsule

Treatment:

Drug: NBI-98854 50 mg capsule

Mild Hepatic Impairment

Experimental group

Description:

single dose of NBI-98854 50 mg capsule

Treatment:

Drug: NBI-98854 50 mg capsule

Moderate Hepatic Impairment

Experimental group

Description:

single dose of NBI-98854 50 mg capsule

Treatment:

Drug: NBI-98854 50 mg capsule

Severe Hepatic Impairment

Experimental group

Description:

single dose of NBI-98854 50 mg capsule

Treatment:

Drug: NBI-98854 50 mg capsule