Evaluation of the Relative Bioavailability of Apraglutide Compared to Reference Formulation in Healthy Subjects: A Randomized, Open-label, Cross-Over Study
- Trial ID
- 2023-504430-22-00
- Protocol
- TA799-018
- Sponsor
- VectivBio AG
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this clinical trial is to evaluate the **bioavailability** of Apraglutide compared to its reference formulation following subcutaneous administration in healthy individuals. Understanding the relative bioavailability is clinically significant as it provides insights into the absorption and systemic availability of Apraglutide, which is crucial for determining its therapeutic efficacy and safety profile. No secondary objectives are specified for this study.
Participants
The clinical trial involves a **healthy** study population comprising both male and female participants. The age range of the participants falls within categories 3 and 4, which typically correspond to adults and older adults. The trial does not focus on a vulnerable population, indicating that the participants are generally in good health. The sponsor has not provided information regarding the total number of participants involved in the study. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet or physical activity, have not been disclosed. The absence of this data suggests that the sponsor has chosen not to share these details.
Plans and Procedures
The clinical trial is designed as a **randomized**, open-label, single-dose, 3-period, 6-sequence cross-over study. The primary aim is to investigate the relative bioavailability of apraglutide compared to a reference formulation following subcutaneous administration. The trial is conducted in **healthy** participants, with the study period estimated to begin on April 3, 2023, and conclude by September 8, 2023. The trial is categorized as a Phase 2 study.
Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as the screening phase to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into different sequences for the cross-over design. Each participant will receive a single dose of the investigational product in each of the three periods, with adequate washout periods between doses to ensure no carryover effects. The sequence of administration is determined by randomization to maintain the integrity of the study design.
Throughout the trial, follow-up visits will be scheduled to monitor the participants' health status and collect necessary data for bioavailability analysis. These visits are crucial for assessing the pharmacokinetic parameters and ensuring participant safety. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the investigational product's bioavailability.
The expected duration of participant involvement spans the entire trial period, from the initial screening to the end-of-study visit. However, conditions such as adverse events, non-compliance with study procedures, or withdrawal of consent may lead to early termination from the study. The trial is structured to ensure rigorous data collection while prioritizing participant safety and adherence to ethical standards.
Treatment
In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of this data precludes a comprehensive description of the treatments used in the study.
Efficacy
The clinical trial is in Phase 2 and is scheduled to have an estimated recruitment start date of April 3, 2023, with an estimated end date of September 8, 2023. The efficacy of the investigational treatment will be assessed through a series of predefined parameters and endpoints. However, specific primary and secondary endpoints, as well as the methods and schedule for measuring, collecting, and analyzing these efficacy parameters, are not detailed in the available data. The trial is categorized under trial category 1, with a trial category ID of 18053. The trial's design and execution will adhere to the standard protocols for Phase 2 clinical trials, focusing on evaluating the treatment's efficacy and safety profile.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Signed and dated Informed Consent Form (ICF) prior to any trial-mandated procedure.
- Male or female subjects aged from 18.0 to 67.0 years (inclusive) at the time of signing the ICF.
- Body mass index range from 18.0 to 35.0 inclusive kg/m2 (inclusive).
- Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception (see Section 7.1.1) during the trial and for 4 weeks after the FU visit.
- Women of childbearing potential with vasectomized partner. Women considered sterilized or infertile, females who have undergone surgical sterilization (bilateral tubectomy, bilateral tubal occlusion, hysterectomy, or bilateral ovariectomy).
- Postmenopausal women. Postmenopausal status is defined as no regular menstrual bleeding for at least 12 months prior to inclusion. Menopause will be confirmed by a serum estradiol concentration of <58 pmol/L and a serum follicle-stimulating hormone (FSH) level of >23 IU/L.
- Male subjects with a female partner of childbearing potential must commit to practice highly effective methods of contraception (e.g., condom, vasectomy) and abstain from sperm donation during the trial and for 4 weeks after the FU visit. Their partners, if they are women of childbearing potential, must agree to practice effective contraception and to use a highly effective method of contraception during the trial and for 4 weeks after the FU visit. See Section 7.1.3.
- Able to participate, willing to give written informed consent, and comply with the trial restriction.
- Subject must be healthy, as determined by medical history, complete physical examination (including vital signs and ECG), and safety laboratory tests (general biochemistry, hematology, urinalysis) including negative tests for human immunodeficiency virus (HIV), hepatitis A immunoglobulin (Ig)M, hepatitis B, and hepatitis C.
Exclusion Criteria
- Body weight less than 50.0 kg and more than 110.0 kg.
- History of clinically significant gastro-intestinal, hepatic, bronchopulmonary, neurological, cardiovascular, endocrine, renal, allergic, or psychiatric disease in the opinion of the Investigator.
- Any clinically relevant abnormal laboratory test results that are not in line with subject status of healthy subject in the opinion of the Investigator.
- If female of child-bearing potential, a positive blood pregnancy test.
- Lactating women.
- Positive urine test for alcohol and drugs of abuse at Screening and on Day -1.
- Use of prohibited medications excepting the use of paracetamol with a maximum dose of 4 g per day for treatment of AEs and the use of hormonal contraceptives during the study as described in Section 10.2.
- Known presence or history of intestinal polyps.
- Known presence or history of any type of cancer.
- Pancreatic events such as chronic and acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0–5.0 × upper limit of normal range) at Screening and on Day -1 of each period.
- Participation in an investigational drug or device study within 30 days prior to Screening.
- Donation of blood over 499 mL within 3 months prior to Screening.
- Donation of plasma within 2 weeks prior to Screening.
- Heavy use of tobacco products (i.e., smokes more than 10 cigarettes per day at the time of Screening).
- 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 clinically significant illness in the previous 28 days before Day 1 of this study as determined by Investigator
- Positive results to HIV antigen/antibody combo, hepatitis A virus (HAV) IgM, hepatitis B surface antigen (HBsAg), hepatitis B core antigen (anti-HBc) or hepatitis C virus (HCV) tests.
- Unwillingness or inability to comply with the study protocol for any other reason.
- Supine pulse rate less than 40 beats per minute or more than 100 beats per minute at Screening. Supine systolic blood pressure below 90 mmHg or higher than 140 mmHg. Supine diastolic blood pressure below 45 mmHg or higher than 90 mmHg at Screening
- Any known skin condition that can affect SC dosing or interpretation of injectireactions.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine, or 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 3 months of Screening.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 The Netherlands | Not Recruiting | 03 Apr 2023 | — |
| Netherlands | — | — | 33 |