NCT02327546已完成1 期
An Open-Label, Randomized, Single-Dose Study to Evaluate the Effects of 325 mg Ferrous Sulfate Tablet (65 mg Iron) on the Pharmacokinetics of 450 mg Dose of AKB-6548 in Healthy Male Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- PK parameters of AKB-6548: Maximum plasma concentration (Cmax)
研究概览
简要总结
The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 18 to 55 years of age with a body mass index between 18 and 30 kg/m2
- •Participants and their partners must use a highly effective form of contraception during the study and for 1 month following discharge from the Clinical Research Unit (CRU)
- •Subjects must discontinue all iron preparations for 14 days prior to study drug administration
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
- •Renal impairment (estimated glomerular filtration rate (eGFR) of <65mL/min)
- •Known active cancer (except non-melanoma skin 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
- •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
AKB-6548
Experimental
AKB-6548
干预措施: AKB-6548 (Drug)
AKB-6548 plus Ferrous Sulfate
Experimental
AKB-6548 plus ferrous sulfate
干预措施: AKB-6548 (Drug)
AKB-6548 plus Ferrous Sulfate
Experimental
AKB-6548 plus ferrous sulfate
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
PK parameters of AKB-6548: Maximum plasma concentration (Cmax)
时间窗: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])
时间窗: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Area under the concentration-time curve from 0 to infinity (AUCinf)
时间窗: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
次要结局
- PK parameters of AKB-6548: Time to maximum plasma concentration (Tmax)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548: Terminal elimination rate constant (λz)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548: Plasma half life (t1/2)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548: Apparent total systemic clearance (CL/F)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- Ratio of metabolite to parent drug for area under the concentration-time curve (AUC)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548: Apparent volume of distribution during the terminal elimination phase (VzF)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (λz)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548 metabolites: Plasma half life (t1/2)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548 metabolites: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- PK parameters of AKB-6548 metabolites: Area under the concentration-time curve from 0 to infinity (AUCinf)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- Ratio of metabolite to parent drug for maximum plasma concentration (Cmax)(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
- Ratio of metabolite to parent drug for are under the curve from time 0 until the last quantifiable concentration (AUC [last])(Multiple timepoint evaluations from pre-dose to 24 hours post-dose)
研究者
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