Short Bowel Syndrome Short Bowel Syndrome
Conditions
Interventions
Volunteers will receive an injection of apraglutide two times: once on Day 2
and once on Day 9. The dose that will be given each time is 5 milligram (mg).
Paracetamol will be given twice: once on Da
Sponsors
VectivBio AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent form (ICF) prior to any trial-mandated procedure 2. Subject must be healthy, as determined by medical history, complete physical examination (including vital signs) and safety laboratory tests (general biochemistry, hematology, urinalysis) including negative tests for human immunodeficiency virus (HIV), hepatitis A, hepatitis B, and hepatitis C 3. Male or female subjects aged from 18 to 45 years inclusive (gastric motility decreases with age) at the time of signing the ICF 4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive 5. Women of childbearing potential having undergone bilateral tubal occlusion or with vasectomized partner. To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy, or bilateral ovariectomy)
Exclusion criteria
Exclusion criteria: 1. Body weight less than 50.0 kg 2. History of clinically significant gastro-intestinal, hepatic, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease 3. Any clinically relevant abnormal laboratory test results that are not in line with subject status of healthy subject 4. Allergy or sensitivity to acetaminophen 5. Known hypersensitivity to the investigational medicinal product (IMP), any of their excipients or drugs of the same class
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of apraglutide administered to healthy subjects. | — |
Countries
Netherlands
Outcome results
None listed