An Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Pharmacokinetics, Bioavailability, and Safety of 3 Tablets of COV155 Administered in Normal, Healthy Subjects Under Fed (High- and Low-Fat Meal) and Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 30
- 主要终点
- Area under the plasma concentration-time curve (AUC)
研究概览
简要总结
A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Males and/or non-pregnant, non-lactating or postmenopausal females, between 18 and 55 years of age with a body mass index ≥ 19 and ≤ 30 kg/m
- •All subjects biologically capable of having children must agree and commit to the use acceptable method(s) of birth control.
排除标准
- •ECG abnormalities or lab values greater than 2 times the upper limit of normal.
- •Positive test results for human immunodeficiency virus (HIV), hepatitis B (HBsAg), or hepatitis C (IgG).
- •Positive urine test results for drugs of abuse or history of drug/alcohol abuse.
- •Use of marijuana, illicit drugs or nicotine-containing products.
- •Donated or had significant loss of whole blood.
- •Taken any prescription or nonprescription drugs, vitamins, minerals, or dietary/herbal supplements.
- •History of abdominal and/or pelvic surgery, cholecystectomy, gastric bypass or gastric band surgery, or cardiothoracic surgery.
- •History of anxiety, tension, agitation, psychiatric disorders, psychosis, or depression requiring hospitalization, psychotherapy, and/or medication.
- •History of acute or chronic gastrointestinal disease or any condition that may interfere with the absorption, distribution, metabolism or excretion of the study treatment.
- •History of seizures or diagnosis of epilepsy or other seizure disorder.
- •History or laboratory evidence of bleeding or clotting disorder or condition.
- •History or laboratory evidence of malignancy, stroke, diabetes, cardiac, renal, liver, and chronic pulmonary disease.
- •Have or have a history of hay fever or seasonal allergies requiring over-the-counter or prescription medications.
研究组 & 干预措施
COV155
干预措施: COV155 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC)
时间窗: 48 hours
To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions
Maximum observed plasma concentration (Cmax)
时间窗: 48 hours
To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions
Time to achieve the maximum observed plasma concentration (Tmax)
时间窗: 48 hours
To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions
次要结局
未报告次要终点