An Open-label Study in Healthy Subjects to Assess the Effect of Once-daily Multiple Dosing of AKB-6548 on the Pharmacokinetics of the CYP2C9 Substrate Celecoxib
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- PK parameters (time to reach Cmax )
研究概览
简要总结
To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.
详细描述
To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone and following multiple daily doses of AKB-6548.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/sq.meters, inclusive.
- •Subjects with the following genotype based upon pharmacogenetic testing results: CYP2C9 EM: *1*1.
排除标准
- •Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
- •Positive serology results for HBsAg, HCV, and HIV at Screening.
- •Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/minute/1.73 sq.meters.
- •Known hypersensitivity to celecoxib or sulfonamides.
- •History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- •Known active cancer or history of chemotherapy use within the previous 24 months.
- •Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
- •Current or past history of gastrointestinal bleeding.
- •Any history of alcohol or drug abuse within the previous year prior to Screening.
- •Subjects with a known history of smoking and/or have used nicotine or nicotine containing products within the past 6 months.
研究组 & 干预措施
Celecoxib
Celecoxib
干预措施: Celecoxib (Drug)
AKB-6548 and Celecoxib
AKB-6548; celecoxib
干预措施: Celecoxib (Drug)
AKB-6548 and Celecoxib
AKB-6548; celecoxib
干预措施: AKB-6548 (Drug)
结局指标
主要结局
PK parameters (time to reach Cmax )
时间窗: pre-dose to 48 hours post-dose
time to reach Cmax for celecoxib
PK parameters (AUC0-inf)
时间窗: from pre-dose to 48 hours post-dose
AUC from time 0 to infinity (AUC0-inf) for celecoxib
PK parameters (Cmax)
时间窗: pre-dose to 48 hours post-dose
maximum observed plasma concentration (Cmax) for celecoxib
PK parameters (AUC0-t)
时间窗: pre-dose to 48 hours post-dose
concentration (AUC0-t) for celecoxib
PK parameters (t½)
时间窗: from pre-dose to 48 hours post-dose
terminal elimination half-life (t½) for celecoxib
PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable)
时间窗: pre-dose to 48 hours post-dose
area under the plasma concentration-time curve from 0 to last quantifiable
PK parameters (CL/F)
时间窗: pre-dose to 48 hours post-dose
apparent oral clearance (CL/F) for celecoxib
PK parameters (Vz/F)
时间窗: pre-dose to 48 hours post-dose
apparent volume of distribution during the terminal phase (Vz/F) for celecoxib
次要结局
- Safety and Tolerability will be measured by vital signs(up to ten days)
- Safety and Tolerability will be measured by clinical assays(up to ten days)
- Safety and Tolerability will be monitoring of adverse events (AEs)(up to ten days)