Short Bowel Syndrome
Conditions
Interventions
The following dose levels of apraglutide will be compared to placebo: 1.0, 5
and 10 mg.
Sponsors
VectivBio AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to sign the ICF; 2. Males or females (at least 2 subjects of each gender for each dose level) 3. 18-40 years of age inclusive; 4. Body Mass Index (BMI) >18.0 and
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating during screening visit; 2. Participation in an investigational drug or device study within 3 months prior to (the first) drug administration in the current study; 3. Positive screen for serology tests (hepatitis B surface antigen [HBsAg], anti-hepatitis C virus [HCV] antibody, and anti-human immunodeficiency virus [HIV] antibody); 4. A history of clinically significant intestinal adhesions and/or chronic abdominal pain; 5. History of proven cholecystitis within the past 3 years except for subjects who underwent cholecystectomy which resolved complaints; 6. Inadequate hepatic function at screening as defined by: bilirubin >2.0 upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 × ULN; alkaline phosphatase (ALP) >2.5 × ULN; or international normalized ratio (INR) >1.5 × ULN; 7. Inadequate renal function as defined by serum creatinine or blood urea nitrogen >2.5 × ULN; 8. Loss of blood or donation of blood or plasma >500 mL within 3 months prior to screening; 9. History of clinically significant drug and/or food allergies or allergy for the administered compound or excipients; 10. History of alcohol and/or drug abuse within the last 12 months; 11. Smoking within the 30 days before the first dose administration and not willing and able to abstain from smoking during the course of the study; 12. Incapability of understanding or not willing to adhere to the trial visit schedules and other protocol requirements; 13. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints -Treatment-emergent (serious) adverse events ((S)AEs). -Concomitant medication -Clinical laboratory tests -Vital signs -ECG -Anti-apraglutide antibodies Pharmacokinetic endpoints may include - The area under the plasma concentration-time curve to the end of the dosing period after the first (AUC1w) and last (AUCtau) dosing; - The maximum plasma concentration (Cmax) after the first and last dosing; - The time to reach maximum plasma concentration (tmax) after the first and last dosing; - The area under the plasma concentration-time curve from zero to t of the last measured concentration above the limit of quantification (AUC0-last) after the last dosing; - The plasma concentration immediately prior to next dosing on Day 8, 15, 22, 29, and 36 (Ctrough); - The terminal disposition rate constant (*z) with the respective half-life (t*) after the last dosing. - Other parameters, including Vz/F, CL/F, and other parameters as appropriate, as well as dose adjusted parameters, may be determined. Pharmacodynamic endpoints - Plasma citrulline - Body weight - Bristol stool scale | — |
Countries
Netherlands
Outcome results
None listed