NCT01365000已完成1 期
A Phase I, Open-label, Randomized, Balanced, Single-dose, Two-Part Study to Assess the Relative Bioavailability of NKTR-118 in Three Formulations Under Fasted (3-Way Crossover) and Fed (2-Way Crossover) Conditions in Male and Non-fertile Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax)
研究概览
简要总结
The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.
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
- •Provision of signed and dated, written informed consent prior to any study-specific procedures
- •Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- •Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range
- •Irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation
- •Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
- •Volunteers must be able to understand and be willing to comply with study procedures, restrictions and requirements
- •Healthy male and non-fertile female volunteers ages 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture
排除标准
- •Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the absorption, distribution, metabolism, and excretion of drugs
- •Current smokers, those who have smoked or used nicotine products within the previous 3 months from the date of screening (Visit 1)
- •Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening or intention to donate blood or blood products during the study or within 3 months after the completion of the study
- •Positive screen for drugs of abuse, or cotinine (nicotine level above 400 ng/mL), at screening or admission and/or positive alcohol test at admission
- •Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
研究组 & 干预措施
NKTR118 Formulation 2
Experimental
Fasted
干预措施: NKTR118 Formulation 2 (Drug)
NKTR118 Formulation 3a
Experimental
FED
干预措施: NKTR118 Formulation 3a (Drug)
NKTR118 Formulation 1a
Experimental
Fed
干预措施: NKTR118 Formulation 1a (Drug)
NKTR118 Formulation 1
Experimental
Fasted
干预措施: NKTR118 Formulation 1 (Drug)
NKTR118 Formulation 3
Experimental
Fasted
干预措施: NKTR118 Formulation 3 (Drug)
结局指标
主要结局
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax)
时间窗: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t))
时间窗: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax)
时间窗: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz)
时间窗: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC).
时间窗: day-1 to day 3
次要结局
- Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing adverse events(Duration day -1 (Visit 2) to follow up (Visit 12))
- Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing 12-Lead Electrocardiograms(Duration day -1 (Visit 2) to follow up (Visit 12))
- Concentration of NKTR-118 in plasma samples after drug intake during Fed condition(Duration: Day 1 to day 4 at the 2 last inhouse stays)
- Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Columbia-Suicide Severity Rating Scale (C-SSRS)(Duration day -1 (Visit 2) to follow up (Visit 12))
- Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Safety Laboratory values(Duration day -1 (Visit 2) to follow up (Visit 12))
研究者
研究点 (1)
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