Status:
COMPLETED
Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief 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 stud...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01910480
Start Date
July 1 2013
End Date
August 1 2013
Last Update
September 5 2013
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283