DRUG
Apraglutide
Peptide analogue of GLP-2
Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation
Status
Completed
Phase
Phase 1
Enrollment
34
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This trial compares the relative bioavailability of apraglutide in dual-chamber syringes (DCS) versus the reference formulation apraglutide in vials.
Full detailed description
This is a single-center, open-label, randomized, three-period, and six-sequence cross-over trial with two washout periods of at least 14 days to compare the relative bioavailability of apraglutide using DCS versus the reference formulation in vials, following SC administrations in healthy male and female subjects. Following consent, subjects will undergo a Screening procedure to see if they are suitable to be enrolled in the trial. Screening may be performed up to 28 days prior to the first injection procedure. All eligible subjects will receive the following treatments in three separate treatment periods: * Treatment A: Single SC dose of 5 mg (400 µL) from DCS at a concentration of 12.5 mg/mL * Treatment B: Two concomitant single SC doses of 2.5 mg (400 µL each) of DCS at a concentration of 6.25 mg/mL * Treatment C: Single SC dose of 5 mg (200 µL) from vial at a concentration of 25 mg/mL of the current formulation-reference There will be a 14-day washout period between the first and second treatment periods and between the second and third treatment periods.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 21, 2023
Study start
May 23, 2023
Primary completion
Sep 22, 2023
Study completion
Sep 22, 2023
Results posted
Not reported
Registry updated
Oct 26, 2024
Outcomes
What the study measures.
Primary outcomes
Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax)
Time frame · 0 to 312 hours post dose in each period
Plasma apraglutide primary PK parameter: AUCinf or AUClast
Time frame · 0 to 312 hours post dose in each period
Secondary outcomes
Time of maximum plasma concentration (tmax)
Time frame · 0 to 312 hours post dose in each period
Terminal elimination rate constant (λz)
Time frame · 0 to 312 hours post dose in each period
Terminal half-life (t½)
Time frame · 0 to 312 hours post dose in each period
Incidence, nature and severity of adverse events (AE) with apraglutide
Time frame · Baseline to Day 79
Clinical chemistry
Time frame · Baseline to Day 79
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 · Baseline to Day 79
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 · Baseline to Day 79
Hemostasis INR will be examined for clinically significant changes. INR levels will be listed by subject. Descriptive statistics will be used to assess any changes in hemostasis results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
Anti-drug antibodies (ADA) analysis
Time frame · Baseline to Day 79
ADA will be will be examined for clinically significant changes
Urine analysis
Time frame · Baseline to Day 79
Urine analysis panel of analytes will be examined for clinically significant changes. Urine analysis data 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.
Occurrence of clinically relevant changes in electrocardiogram
Time frame · Baseline to Day 79
ECG QT Interval
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 67 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Age between 18 and 67 years inclusive * Subjects 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 ≤35.0 kg/m2; and a total body weight of \>50 kg * 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 4 weeks after (EOT) visit. Exclusion Criteria: * History of clinically significant gastrointestinal, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease * Known hypersensitivity to the investigational medicinal products (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 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) at Screening or on Day -1 of each period * Participation in an investigational drug or device study within 30 days prior to screening * Donation of blood over 500 mL within 3 months prior to screening * Use of tobacco products (i.e., smokes more than 10 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), hepatitis B core antigen (anti-HBc) 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
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
GlyPharma Therapeutics · SBS - Short Bowel Syndrome
Phase 1 / Phase 2
Completed
8
2024-10
Related PeptideStat pages
Put the record in context.
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