Completed

NCT Number: NCT01910480

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

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

NBI-98854 50 mg capsule once daily

Drug

Ketoconazole 400 mg (200 mg twice daily)

Drug

Primary outcomes

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

Time frame: Up to 31 days

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jul 29, 2013
Registry last updated: Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.