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

A Phase 1, Open-Label 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.

Study Overview

• Status: Completed
• Conditions: Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
• Intervention / Treatment: Drug: NBI-98854 50 mg capsule once daily; Drug: Ketoconazole 400 mg (200 mg twice daily)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 alone	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	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	Up to 31 days

Collaborators and Investigators

• Sponsor: Neurocrine Biosciences

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (ESTIMATE): July 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 3, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: NBI-98854-1302