A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Center, Multiple-Dose, Parallel Trial Evaluating the Impact of Apraglutide on Gastric Emptying of Liquids in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- VectivBio AG
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Time at which the maximum plasma concentration is observed (tmax) of acetaminophen
研究概览
简要总结
The primary objective is to assess the effect of apraglutide on gastric emptying of liquids in healthy subjects, as measured by the PK of acetaminophen mixed with a liquid meal.
详细描述
This is a single-center, double-blind, randomized, multiple-dose, parallel trial with a total duration of up to 50 days. The trial population will consist of healthy volunteers. Eligible subjects will be randomized to receive either subcutaneous (SC) apraglutide or matching placebo. The effect of apraglutide on gastric emptying of liquids will be assessed by the measure of PK of acetaminophen mixed with a liquid meal.
There will be two treatment periods, occurring according to the same sequence. In Period 1 acetaminophen will be given on Day 1, apraglutide/placebo will be injected on Day2. In Period 2 apraglutide/placebo will be injected on Day 9 and acetaminophen will be given on Day 10. This will allow to assess the PK of acetaminophen without the effect of apraglutide in Period 1, and to assess the PK of acetaminophen at the maximum concentration of apraglutide in Period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The pharmacist and designated staff will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years inclusive
- •Subjects who are willing and able to comply with the study procedures
- •Subjects able to understand and willing to sign the informed consent
- •Body mass index (BMI) of ≥18.0 to ≤30.0 kg/m2; and a total body weight of >50 kg (110 lb).
- •Women of childbearing potential (WOCBP) having undergone bilateral tubal occlusion or with vasectomized partner. Sterilized or infertile or postmenopausal females.
- •Male subjects with a WOCBP partner using highly effective methods of contraception and agreeing on no sperm donation during the trial and for 2 weeks after (EOT) visit.
排除标准
- •History of clinically significant GI, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease
- •Known hypersensitivity to the investigational medicinal product (IMP), any of their excipients or drugs of the same class
- •If capable of reproduction, unwilling to use an effective form of contraception
- •If a WOCBP, a positive urine/blood pregnancy test
- •Breast-feeding women
- •Positive urine/blood test for alcohol and drugs of abuse
- •Use of prohibited medications or herbal remedies
- •Known presence or history of intestinal polyps
- •Known presence or history of any type of cancer
- •Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0-5.0×upper limit of normal range)
- •Participation in an investigational drug or device study within 30 days prior to Screening
- •Donation of blood over 500 mL within 2 months prior to Screening
- •Use of tobacco products (i.e., smokes more than 5 cigarettes per day or equivalent)
- •Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
- •Any intercurrent clinically significant illness in the previous 28 days before Day 1 of this study
- •Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo, hepatitis A (HAV IGM), hepatitis B surface antigen (HBsAgB), or hepatitis C virus (HCV)
- •Unwillingness or inability to comply with the study protocol for any other reason
研究组 & 干预措施
Apraglutide SC injections
干预措施: Apraglutide (Drug)
Apraglutide SC injections
干预措施: Acetaminophen (Drug)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Time at which the maximum plasma concentration is observed (tmax) of acetaminophen
时间窗: 0-300 Minutes
Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)
时间窗: 0-14 hours
Area under the acetaminophen concentration-time curve: AUC0-300min
时间窗: 0-300 Minutes
Area under the acetaminophen concentration-time curve: AUC0-60min
时间窗: 0-60 Minutes
Maximum plasma concentration (Cmax) of acetaminophen
时间窗: 0-300 Minutes
次要结局
- Weight(Through study completion, up to 24 days)
- Anti-drug antibodies (ADA) analysis(Through study completion, up to 24 days)
- Clinical chemistry(Through study completion, up to 24 days)
- Occurrence of clinically relevant changes in electrocardiogram(Through study completion, up to 24 days)
- Hemostasis(Through study completion, up to 24 days)
- Urine analysis(Through study completion, up to 24 days)
- Occurrence of clinically relevant changes in vital signs(Through study completion, up to 24 days)
- Height(Through study completion, up to 24 days)
- Physical examination(Through study completion, up to 24 days)
- Hematology(Through study completion, up to 24 days)
- Changes in body temperature in °C(Through study completion, up to 24 days)
- The incidence, nature and severity of adverse events (AEs) with apraglutide(Through study completion, up to 24 days)