Clinical trial NCT01916993: Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility 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.

Primary outcomes:
measure: Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854
timeFrame: 45 minutes prior to NBI-98854 dosing, and 15, 30, 45 minutes, and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose
measure: Number of Participants with Adverse Events following dosing with NBI-98854
timeFrame: Up to 36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research
state: Colorado
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: Davita Clinical Research
state: Minnesota
Study officials:
affiliation: Neurocrine Biosciences
name: Chris O'Brien, MD
role: STUDY_DIRECTOR
References: