Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Primary Purpose
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NBI-98854 50 mg capsule
Sponsored by
About this trial
This is an interventional basic science trial for Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
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.
Sites / Locations
- DaVita Clinical Research
- Orlando Clinical Research Center
- Davita Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy Volunteers
Mild Hepatic Impairment
Moderate Hepatic Impairment
Severe Hepatic Impairment
Arm Description
single dose of NBI-98854 50 mg capsule
single dose of NBI-98854 50 mg capsule
single dose of NBI-98854 50 mg capsule
single dose of NBI-98854 50 mg capsule
Outcomes
Primary Outcome Measures
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854
Number of Participants with Adverse Events following dosing with NBI-98854
Secondary Outcome Measures
Full Information
NCT ID
NCT01916993
First Posted
August 2, 2013
Last Updated
January 14, 2014
Sponsor
Neurocrine Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT01916993
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
single dose of NBI-98854 50 mg capsule
Arm Title
Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
single dose of NBI-98854 50 mg capsule
Arm Title
Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
single dose of NBI-98854 50 mg capsule
Arm Title
Severe Hepatic Impairment
Arm Type
Experimental
Arm Description
single dose of NBI-98854 50 mg capsule
Intervention Type
Drug
Intervention Name(s)
NBI-98854 50 mg capsule
Primary Outcome Measure Information:
Title
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854
Time Frame
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
Title
Number of Participants with Adverse Events following dosing with NBI-98854
Time Frame
Up to 36 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris O'Brien, MD
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
DaVita Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Davita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
We'll reach out to this number within 24 hrs