Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apraglutide SC injections | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apraglutide | Drug | Peptide analogue of GLP-2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Height | In cm | Through study completion, up to 24 days |
| Weight | In kg | Through study completion, up to 24 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Masior | VectivBio AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Clinical Research Unit | Groningen | Netherlands |
Not provided
| ID | Term |
|---|---|
| C000710330 | apraglutide |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
The pharmacist and designated staff will be unblinded.
| Placebo |
| Drug |
Matching placebo to apraglutide |
|
| Acetaminophen | Drug | Acetaminophen mixed with a liquid meal |
|
| Physical examination | Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat. | 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 |
| Clinical chemistry | 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. | Through study completion, up to 24 days |
| Hematology | 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. | Through study completion, up to 24 days |
| Hemostasis | Hemostasis INR will be examined for clinically significant changes | Through study completion, up to 24 days |
| Anti-drug antibodies (ADA) analysis | ADA will be will be examined for clinically significant changes | Through study completion, up to 24 days |
| Urine analysis | Urine analysis panel of analytes will be examined for clinically significant changes | Through study completion, up to 24 days |
| Occurrence of clinically relevant changes in vital signs | Systolic and diastolic blood pressure in mmHg | Through study completion, up to 24 days |
| Occurrence of clinically relevant changes in vital signs | Pulse rate in Beats per Minute | Through study completion, up to 24 days |
| Changes in body temperature in °C | Through study completion, up to 24 days |
| Occurrence of clinically relevant changes in electrocardiogram | ECG QT Interval | Through study completion, up to 24 days |
| Occurrence of clinically relevant changes in electrocardiogram | ECG PR interval | Through study completion, up to 24 days |
| Occurrence of clinically relevant changes in electrocardiogram | ECG QRS interval | Through study completion, up to 24 days |
| Occurrence of clinically relevant changes in electrocardiogram | ECG rhythm | Through study completion, up to 24 days |
| Aniline Compounds |
| D000588 | Amines |