DRUG
Apraglutide
Peptide analogue of GLP-2
Evaluation of Apraglutide on Gastric Emptying
Status
Completed
Phase
Phase 1
Enrollment
42
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Matching placebo to apraglutide
DRUG
Acetaminophen
Acetaminophen mixed with a liquid meal
Timeline
From registration to results.
First posted
Aug 16, 2023
Study start
Mar 2, 2023
Primary completion
Jul 24, 2023
Study completion
Jul 24, 2023
Results posted
Not reported
Registry updated
Oct 24, 2024
Outcomes
What the study measures.
Primary outcomes
Maximum plasma concentration (Cmax) of acetaminophen
Time frame · 0-300 Minutes
Time at which the maximum plasma concentration is observed (tmax) of acetaminophen
Time frame · 0-300 Minutes
Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)
Time frame · 0-14 hours
Area under the acetaminophen concentration-time curve: AUC0-300min
Time frame · 0-300 Minutes
Area under the acetaminophen concentration-time curve: AUC0-60min
Time frame · 0-60 Minutes
Secondary outcomes
Height
Time frame · Through study completion, up to 24 days
In cm
Weight
Time frame · Through study completion, up to 24 days
In kg
Physical examination
Time frame · Through study completion, up to 24 days
Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat.
The incidence, nature and severity of adverse events (AEs) with apraglutide
Time frame · Through study completion, up to 24 days
Clinical chemistry
Time frame · Through study completion, up to 24 days
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.
Hematology
Time frame · Through study completion, up to 24 days
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.
Hemostasis
Time frame · Through study completion, up to 24 days
Hemostasis INR will be examined for clinically significant changes
Anti-drug antibodies (ADA) analysis
Time frame · Through study completion, up to 24 days
ADA will be will be examined for clinically significant changes
Urine analysis
Time frame · Through study completion, up to 24 days
Urine analysis panel of analytes will be examined for clinically significant changes
Occurrence of clinically relevant changes in vital signs
Time frame · Through study completion, up to 24 days
Systolic and diastolic blood pressure in mmHg
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Age between 18 and 45 years inclusive * Subjects who are 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 ≤30.0 kg/m2; and a total body weight of \>50 kg (110 lb). * 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 2 weeks after (EOT) visit. Exclusion Criteria: * History of clinically significant GI, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease * Known hypersensitivity to the investigational medicinal product (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 urine/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) * Participation in an investigational drug or device study within 30 days prior to Screening * Donation of blood over 500 mL within 2 months prior to Screening * Use of tobacco products (i.e., smokes more than 5 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), or hepatitis C virus (HCV) * Unwillingness or inability to comply with the study protocol for any other reason
Study locations
1 registered sites.
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
ICON Clinical Research Unit
Groningen, Netherlands
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Apraglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Phase 2
Terminated
31
2025-10
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
VectivBio AG · Hepatic Impairment
Phase 1
Completed
16
2025-07
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
VectivBio AG · Short Bowel Syndrome
Phase 3
Active, not recruiting
158
2025-07
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
VectivBio AG · Short Bowel Syndrome
Phase 2
Completed
10
2025-06
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
VectivBio AG · Short Bowel Syndrome
Phase 3
Completed
164
2024-11
Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support
GlyPharma Therapeutics · Short Bowel Syndrome
Phase 1 / Phase 2
Completed
8
2024-10
Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.
VectivBio AG · Chronic Kidney Disease
Phase 1
Completed
16
2024-10
Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation
VectivBio AG · Healthy Subjects
Phase 1
Completed
34
2024-10
Related PeptideStat pages
Put the record in context.
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