Evaluation of Apraglutide on Gastric Emptying

October 23, 2024 updated by: VectivBio AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • ICON Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Acetaminophen
Acetaminophen mixed with a liquid meal
Drug: Placebo
Matching placebo to apraglutide
Experimental: Apraglutide SC injections
Drug: Apraglutide
Peptide analogue of GLP-2
Drug: Acetaminophen
Acetaminophen mixed with a liquid meal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum plasma concentration (Cmax) of acetaminophen
Time Frame: 0-300 Minutes
0-300 Minutes
Time at which the maximum plasma concentration is observed (tmax) of acetaminophen
Time Frame: 0-300 Minutes
0-300 Minutes
Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)
Time Frame: 0-14 hours
0-14 hours
Area under the acetaminophen concentration-time curve: AUC0-300min
Time Frame: 0-300 Minutes
0-300 Minutes
Area under the acetaminophen concentration-time curve: AUC0-60min
Time Frame: 0-60 Minutes
0-60 Minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: Through study completion, up to 24 days
In cm
Through study completion, up to 24 days
Weight
Time Frame: Through study completion, up to 24 days
In kg
Through study completion, up to 24 days
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.
Through study completion, up to 24 days
The incidence, nature and severity of adverse events (AEs) with apraglutide
Time Frame: Through study completion, up to 24 days
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.
Through study completion, up to 24 days
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.
Through study completion, up to 24 days
Hemostasis
Time Frame: Through study completion, up to 24 days
Hemostasis INR will be examined for clinically significant changes
Through study completion, up to 24 days
Anti-drug antibodies (ADA) analysis
Time Frame: Through study completion, up to 24 days
ADA will be will be examined for clinically significant changes
Through study completion, up to 24 days
Urine analysis
Time Frame: Through study completion, up to 24 days
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
Time Frame: Through study completion, up to 24 days
Systolic and diastolic blood pressure in mmHg
Through study completion, up to 24 days
Occurrence of clinically relevant changes in vital signs
Time Frame: Through study completion, up to 24 days
Pulse rate in Beats per Minute
Through study completion, up to 24 days
Changes in body temperature in °C
Time Frame: Through study completion, up to 24 days
Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time Frame: Through study completion, up to 24 days
ECG QT Interval
Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time Frame: Through study completion, up to 24 days
ECG PR interval
Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time Frame: Through study completion, up to 24 days
ECG QRS interval
Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time Frame: Through study completion, up to 24 days
ECG rhythm
Through study completion, up to 24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VectivBio AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tomasz Masior, VectivBio AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TA799-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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