A Phase 1, Open-Label, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation Versus the Current Capsule Formulation of PPI-668 in Healthy Adult Volunteers
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
- PPI-668 maximum observed plasma concentration (Cmax)
研究概览
简要总结
This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- •Must be between 18 and 55 years of age, inclusive.
- •Must be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
- •Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m
- •Must be HIV-1 antibody negative.
- •Must be hepatitis B (HBV) surface antigen negative.
- •Must be hepatitis C (HCV) antibody negative.
排除标准
- •Pregnant or lactating subjects.
- •Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
- •Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
- •Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
- •Have poor venous access and unable to donate blood.
- •Have donated blood within 56 days of study dosing.
- •Have donated plasma within 7 days of study dosing.
- •Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or contraceptive medications.
研究组 & 干预措施
PPI-668 tablet followed by capsule
On day 1 one 200 mg PPI-668 tablet will be administered; on day 8 two 100 mg PPI-668 capsules will be administered
干预措施: PPI-668 tablet (Drug)
PPI-668 capsule followed by tablet
On day 1 two 100 mg PPI-668 capsules will be administered; on day 8 one 200 mg PPI-668 tablet will be administered
干预措施: PPI-668 capsule (Drug)
PPI-668 capsule followed by tablet
On day 1 two 100 mg PPI-668 capsules will be administered; on day 8 one 200 mg PPI-668 tablet will be administered
干预措施: PPI-668 tablet (Drug)
PPI-668 tablet followed by capsule
On day 1 one 200 mg PPI-668 tablet will be administered; on day 8 two 100 mg PPI-668 capsules will be administered
干预措施: PPI-668 capsule (Drug)
结局指标
主要结局
PPI-668 maximum observed plasma concentration (Cmax)
时间窗: Days 1 - 8
PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
时间窗: Days 1 - 8
PPI-668 area under the curve from time zero to infinity (AUC 0-inf)
时间窗: Days 1 - 8
次要结局
- number of participants with adverse events(Days 1 - 8)
- number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels(Days 1 - 8)