Clinical trial NCT05995704: Evaluation of Apraglutide on Gastric Emptying
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Gastric emptying
Pharmacokinetics of acetaminophen
Lead sponsor: VectivBio AG
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of acetaminophen
timeFrame: 0-300 Minutes
measure: Time at which the maximum plasma concentration is observed (tmax) of acetaminophen
timeFrame: 0-300 Minutes
measure: Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)
timeFrame: 0-14 hours
measure: Area under the acetaminophen concentration-time curve: AUC0-300min
timeFrame: 0-300 Minutes
measure: Area under the acetaminophen concentration-time curve: AUC0-60min
timeFrame: 0-60 Minutes
Secondary outcomes:
measure: Height
timeFrame: Through study completion, up to 24 days
measure: Weight
timeFrame: Through study completion, up to 24 days
measure: Physical examination
timeFrame: Through study completion, up to 24 days
measure: The incidence, nature and severity of adverse events (AEs) with apraglutide
timeFrame: Through study completion, up to 24 days
measure: Clinical chemistry
timeFrame: Through study completion, up to 24 days
measure: Hematology
timeFrame: Through study completion, up to 24 days
measure: Hemostasis
timeFrame: Through study completion, up to 24 days
measure: Anti-drug antibodies (ADA) analysis
timeFrame: Through study completion, up to 24 days
measure: Urine analysis
timeFrame: Through study completion, up to 24 days
measure: Occurrence of clinically relevant changes in vital signs
timeFrame: Through study completion, up to 24 days
measure: Occurrence of clinically relevant changes in vital signs
timeFrame: Through study completion, up to 24 days
measure: Changes in body temperature in °C
timeFrame: Through study completion, up to 24 days
measure: Occurrence of clinically relevant changes in electrocardiogram
timeFrame: Through study completion, up to 24 days
measure: Occurrence of clinically relevant changes in electrocardiogram
timeFrame: Through study completion, up to 24 days
measure: Occurrence of clinically relevant changes in electrocardiogram
timeFrame: Through study completion, up to 24 days
measure: Occurrence of clinically relevant changes in electrocardiogram
timeFrame: Through study completion, up to 24 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON Clinical Research Unit
Study officials:
affiliation: VectivBio AG
name: Tomasz Masior
role: STUDY_DIRECTOR
References: