Evaluation of Apraglutide on Gastric Emptying

NCT ID: NCT05995704

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2023-07-24

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Apraglutide SC injections

Group Type: EXPERIMENTAL

Apraglutide

Intervention Type: DRUG

Peptide analogue of GLP-2

Acetaminophen

Intervention Type: DRUG

Acetaminophen mixed with a liquid meal

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to apraglutide

Acetaminophen

Intervention Type: DRUG

Acetaminophen mixed with a liquid meal

Interventions

Apraglutide

Peptide analogue of GLP-2

Intervention Type: DRUG

Placebo

Matching placebo to apraglutide

Intervention Type: DRUG

Acetaminophen

Acetaminophen mixed with a liquid meal

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VectivBio AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomasz Masior

Role: STUDY_DIRECTOR

VectivBio AG

Locations

ICON Clinical Research Unit

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

TA799-020

Identifier Type: -

Identifier Source: org_study_id