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A Randomized, Open-label, Single Dose, 3-Period, 6-Sequence Cross-Over Trial to Investigate the Relative Bioavailability of Apraglutide Versus the Reference Formulation Following Subcutaneous Administrations.
EU CTIS ID: 2023-504430-22-00
What this study is testing
To assess the relative bioavailability of apraglutide in DCS compared to the reference formulation apraglutide in vials.
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Body weight less than 50.0 kg and more than 110.0 kg.
- 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).
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Body weight less than 50.0 kg and more than 110.0 kg.
- 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
- History of clinically significant gastro-intestinal, hepatic, bronchopulmonary, neurological, cardiovascular, endocrine, renal, allergic, or psychiatric disease in the opinion of the Investigator.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.