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CompletedNCT01910480Updated Sep 5, 2013

Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects

A Phase 1 interventional study of NBI-98854 50 mg capsule once daily and Ketoconazole 400 mg (200 mg twice daily) in Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects, sponsored by Neurocrine Biosciences. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-05.

Sponsored by Neurocrine Biosciences · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purposes of this study are to: learn about the safety of the study drug (NBI-98854); learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of the investigational study drug after taking it alone and with ketoconazole. Ketoconazole is known to affect the PK of many drugs and is studied to more safely prescribe medications.

02

Conditions studied

  • Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
03

In context

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male or female volunteer, 18 to 40 years of age.
  • 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.
  • Be in good general health and expected to complete the clinical study as designed.
  • Have a body mass index (BMI) of 18 to 30 kg/m2 (both inclusive).

Exclusion criteria

Exclusion Criteria:

  • Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
  • Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start.
  • Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start.
  • Report use of tobacco and/or nicotine-containing products within 3 months of study start.
  • Have a known history of neuroleptic malignant syndrome.
  • Have a significant risk of suicidal or violent behavior.
  • Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    NBI-98854 followed by NBI-98854 with ketoconazole

    50 mg NBI-98854 on Study Days 1 and 6 and 200 mg ketoconazole twice daily on Study Days 5 through 9.

    Drug: NBI-98854 50 mg capsule once daily · Drug: Ketoconazole 400 mg (200 mg twice daily)

Interventions

  • DrugNBI-98854 50 mg capsule once daily
  • DrugKetoconazole 400 mg (200 mg twice daily)
06

What researchers measure

Primary outcomes

  1. Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 alone

    Time frame: 45 minutes prior to NBI-98854 dosing, and at 15, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 48, 72 and 96 hours postdose

  2. Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 concomitantly with ketoconazole

    Time frame: at 45 minutes prior to NBI-98854 dosing, and at 15, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 48, 72 and 96 hours postdose

  3. Number of Participants with Adverse Events following dosing with NBI-98854

    Time frame: Up to 31 days

07

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01910480
Lead sponsor
Neurocrine Biosciences
Responsible party
Sponsor
First posted
Jul 29, 2013
Start date
Jul 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Sep 5, 2013

Study contacts

Chris O'Brien, MD
study director · Neurocrine Biosciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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