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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neurocrine Biosciences
• Treatments: Ketoconazole

Criteria

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.