Status:
COMPLETED
Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation
Lead Sponsor:
VectivBio AG
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-67 years
Phase:
PHASE1
Brief Summary
This trial compares the relative bioavailability of apraglutide in dual-chamber syringes (DCS) versus the reference formulation apraglutide in vials.
Detailed Description
This is a single-center, open-label, randomized, three-period, and six-sequence cross-over trial with two washout periods of at least 14 days to compare the relative bioavailability of apraglutide usi...
Eligibility Criteria
Inclusion
- Age between 18 and 67 years inclusive
- Subjects 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 ≤35.0 kg/m2; and a total body weight of \>50 kg
- 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 4 weeks after (EOT) visit.
Exclusion
- History of clinically significant gastrointestinal, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease
- Known hypersensitivity to the investigational medicinal products (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 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) at Screening or on Day -1 of each period
- Participation in an investigational drug or device study within 30 days prior to screening
- Donation of blood over 500 mL within 3 months prior to screening
- Use of tobacco products (i.e., smokes more than 10 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), hepatitis B core antigen (anti-HBc) or hepatitis C virus (HCV)
- Unwillingness or inability to comply with the study protocol for any other reason
Key Trial Info
Start Date :
May 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06002555
Start Date
May 23 2023
End Date
September 22 2023
Last Update
October 26 2024
Active Locations (1)
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1
ICON Clinical Research Unit
Groningen, Netherlands