Healthy SubjectsPhase 1NCT05995704
Evaluation of Apraglutide on Gastric Emptying
A Phase 1 study testing Apraglutide and Acetaminophen in people with Healthy Subjects, run by VectivBio AG at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Apraglutide and Acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Mar 2023to 24 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Apraglutide, Placebo, Acetaminophen
- Keywords
- Gastric emptying, Pharmacokinetics of acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApraglutideDrug
Peptide analogue of GLP-2
PlaceboDrug
Matching placebo to apraglutide
AcetaminophenDrug
Acetaminophen mixed with a liquid meal
| Study group | Role | What they receive |
|---|---|---|
| Apraglutide SC injections | Experimental | Not described Receives: Drug: Apraglutide; Drug: Acetaminophen |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of acetaminophen
Measured: 0-300 Minutes
Time at which the maximum plasma concentration is observed (tmax) of acetaminophen
Measured: 0-300 Minutes
Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)
Measured: 0-14 hours
Area under the acetaminophen concentration-time curve: AUC0-300min
Measured: 0-300 Minutes
Area under the acetaminophen concentration-time curve: AUC0-60min
Measured: 0-60 Minutes
Secondary outcomes (16)
Height
In cm
Measured: Through study completion, up to 24 days
Weight
In kg
Measured: Through study completion, up to 24 days
Physical examination
Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat.
Measured: Through study completion, up to 24 days
The incidence, nature and severity of adverse events (AEs) with apraglutide
Measured: Through study completion, up to 24 days
Clinical chemistry
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.
Measured: Through study completion, up to 24 days
Hematology
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.
Measured: Through study completion, up to 24 days
Hemostasis
Hemostasis INR will be examined for clinically significant changes
Measured: Through study completion, up to 24 days
Anti-drug antibodies (ADA) analysis
ADA will be will be examined for clinically significant changes
Measured: Through study completion, up to 24 days
Urine analysis
Urine analysis panel of analytes will be examined for clinically significant changes
Measured: Through study completion, up to 24 days
Occurrence of clinically relevant changes in vital signs
Systolic and diastolic blood pressure in mmHg
Measured: Through study completion, up to 24 days
Occurrence of clinically relevant changes in vital signs
Pulse rate in Beats per Minute
Measured: Through study completion, up to 24 days
Changes in body temperature in °C
Measured: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
ECG QT Interval
Measured: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
ECG PR interval
Measured: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
ECG QRS interval
Measured: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
ECG rhythm
Measured: Through study completion, up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start2 Mar 2023
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- VectivBio AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Masior, Study director, VectivBio AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995704
- Sponsor's protocol ID
- TA799-020
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2023
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05995704
- Acronym / sponsor ID
- TA799-020
- Conditions
- Healthy Subjects
- Keywords
- Gastric emptying, Pharmacokinetics of acetaminophen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- VectivBio AGIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apraglutide SC injections | Experimental | Drug: Apraglutide, Drug: Acetaminophen |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Acetaminophen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApraglutidePeptide analogue of GLP-2 | Drug | Apraglutide SC injections |
| PlaceboMatching placebo to apraglutide | Drug | Placebo |
| AcetaminophenAcetaminophen mixed with a liquid meal | Drug | Apraglutide SC injections, Placebo |
Primary outcome
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
16 secondary outcomes
Height
Time frame: Through study completion, up to 24 days
Weight
Time frame: Through study completion, up to 24 days
Physical examination
Time frame: 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
Clinical chemistry
Time frame: Through study completion, up to 24 days
Hematology
Time frame: Through study completion, up to 24 days
Hemostasis
Time frame: Through study completion, up to 24 days
Anti-drug antibodies (ADA) analysis
Time frame: Through study completion, up to 24 days
Urine analysis
Time frame: Through study completion, up to 24 days
Occurrence of clinically relevant changes in vital signs
Time frame: Through study completion, up to 24 days
Occurrence of clinically relevant changes in vital signs
Time frame: Through study completion, up to 24 days
Changes in body temperature in °C
Time frame: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Through study completion, up to 24 days
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Through study completion, up to 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Masior study director
VectivBio AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apraglutide and Acetaminophen in people with Healthy Subjects, run by VectivBio AG at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) of acetaminophen (time frame: 0-300 Minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.