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

Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916993
• Other study ID #: NBI-98854-1303
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2013
• Last updated: January 14, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects

Intervention

Drug:
• NBI-98854 50 mg capsule

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Lakewood	Colorado
United States	Davita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854		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	No
Primary	Number of Participants with Adverse Events following dosing with NBI-98854		Up to 36 days	Yes