A Phase 1, Open-Label Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 alone
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: NBI-98854 50 mg capsule once daily (Drug)
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.
干预措施: Ketoconazole 400 mg (200 mg twice daily) (Drug)
结局指标
主要结局
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 alone
时间窗: 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
时间窗: 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
时间窗: Up to 31 days
次要结局
未报告次要终点