Status:
COMPLETED
Evaluation of Apraglutide on Gastric Emptying
Lead Sponsor:
VectivBio AG
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05995704
Start Date
March 2 2023
End Date
July 24 2023
Last Update
October 24 2024
Active Locations (1)
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1
ICON Clinical Research Unit
Groningen, Netherlands