Evaluation of Apraglutide on Gastric Emptying
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT05995704
- Lead Sponsor
- VectivBio AG
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Acetaminophen - Placebo Placebo - Apraglutide SC injections Apraglutide - Apraglutide SC injections Acetaminophen -
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) of acetaminophen 0-300 Minutes Time at which the maximum plasma concentration is observed (tmax) of acetaminophen 0-300 Minutes Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated) 0-14 hours Area under the acetaminophen concentration-time curve: AUC0-300min 0-300 Minutes Area under the acetaminophen concentration-time curve: AUC0-60min 0-60 Minutes
- Secondary Outcome Measures
Name Time Method Weight Through study completion, up to 24 days In kg
Anti-drug antibodies (ADA) analysis Through study completion, up to 24 days ADA will be will be examined for clinically significant changes
Clinical chemistry Through study completion, up to 24 days Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Clinical chemistry analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.Occurrence of clinically relevant changes in electrocardiogram Through study completion, up to 24 days ECG rhythm
Hemostasis Through study completion, up to 24 days Hemostasis INR will be examined for clinically significant changes
Urine analysis Through study completion, up to 24 days Urine analysis panel of analytes will be examined for clinically significant changes
Occurrence of clinically relevant changes in vital signs Through study completion, up to 24 days Pulse rate in Beats per Minute
Height Through study completion, up to 24 days In cm
Physical examination Through study completion, up to 24 days Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat.
Hematology Through study completion, up to 24 days Hematology panel of analytes will be examined for clinically significant changes.
Hematology analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.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
Trial Locations
- Locations (1)
ICON Clinical Research Unit
🇳🇱Groningen, Netherlands