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
- Conditions
- Short Bowel Syndrome
- Registration Number
- NL-OMON53626
- Lead Sponsor
- VectivBio AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the effect of apraglutide on gastric emptying of liquids in healthy<br /><br>subjects, as measured by the PK of acetaminophen mixed with a liquid meal. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of apraglutide administered to healthy<br /><br>subjects. </p><br>