Investigation of AGMB-129 and Midazolam Interaction in Healthy Subjects for Fibrostenotic Crohn’s Disease Management
- Trial ID
- 2023-504461-23-00
- Sponsor
- Agomab Spain S.L.U.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **drug-drug interaction** between AGMB-129 and midazolam in healthy participants. Understanding these interactions is clinically relevant as it can inform dosing adjustments and safety considerations for patients with **fibrostenotic Crohn’s disease** who may require treatment with these medications. No secondary objectives are provided in the available data.
Participants
The clinical trial involves participants diagnosed with **fibrostenotic Crohn's disease**. The study population includes both male and female subjects, with an age range categorized under code "3," which typically represents adults. The trial also includes a vulnerable population, although specific details regarding the nature of this vulnerability are not provided. The sponsor has not disclosed the total number of participants involved in the study. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The absence of detailed inclusion or exclusion criteria suggests that the trial may have broad eligibility parameters, but this cannot be confirmed without further information.
Plans and Procedures
The clinical trial is designed to evaluate the **drug-drug interaction** between AGMB-129 and Midazolam in healthy participants. This study is conducted as a **Phase 3** trial, which is a critical stage in the clinical research process, focusing on the efficacy and safety of the investigational drug combination. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is June 21, 2023, with an anticipated end date of September 4, 2023, indicating a total trial duration of approximately two and a half months.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit is crucial for ensuring that only suitable candidates are enrolled in the trial. Following the screening, participants will be randomly assigned to receive either the investigational drug combination or a control, with neither the participants nor the investigators aware of the group assignments, maintaining the double-blind nature of the study. Throughout the trial, follow-up visits will be scheduled to monitor the participants' health, assess the pharmacokinetics of the drugs, and collect data on any adverse events. These visits are essential for evaluating the interaction between AGMB-129 and Midazolam and ensuring participant safety.
The end-of-study visit marks the conclusion of the participant's involvement in the trial. During this visit, final assessments will be conducted to gather comprehensive data on the study's primary and secondary endpoints. The expected length of participant involvement is aligned with the overall trial duration, subject to individual adherence to the study protocol. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with the study requirements, or choose to withdraw consent. Such conditions are in place to prioritize participant safety and the integrity of the trial data.
Treatment
The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.
Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.
Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be described. The absence of these details limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.
Efficacy
The clinical trial is in Phase 3, with an estimated recruitment start date of June 21, 2023, and an estimated end date of September 4, 2023. Efficacy will be assessed through a structured evaluation process, although specific parameters or endpoints for efficacy assessment are not provided. The trial will follow a systematic approach to measure, collect, and analyze data, adhering to the standards expected in Phase 3 trials. The methods and schedule for these assessments are not detailed in the available information. The trial's design will ensure that efficacy is evaluated objectively and consistently throughout the study duration.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed, indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study.
- Male or female, between 18 and 55 years old (extremes included) on the date of signing the ICF
- Body weight of at least 50.0 kg for men and 45.0 kg for women, and a body mass index (BMI) between 19.0 and 30.0 kg/m2 (extremes included) at screening
- a) Male participant is eligible to participate if: o He is vasectomized, OR o He agrees to the following during the intervention period and for at least 4 weeks after the last administration of IP: Refrain from donating fresh unwashed semen, Plus either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR Must agree to use a male condom when: Having sexual intercourse with a woman of childbearing potential who is not currently pregnant. Engaging in any activity that allows for passage of ejaculate to another person. b) Female participant Is eligible to participate if she is not pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study, and at least one of the following conditions applies: - Is a woman of nonchildbearing potential (WONCBP). OR - Is a woman of childbearing potential (WOCBP) and agrees to use a highly effective contraceptive method (with a failure rate of <1% per year) OR be abstinent from heterosexual intercourse as their preferred method and usual lifestyle, during the intervention period and for at least 4 weeks after the last administration of IP. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first administration of IP. Must agree not to donate eggs during the study and for at least 4 weeks after last administration of IP
- Female participants must have a negative highly sensitive serum (beta human chorionic gonadotropin [β-hCG]) pregnancy test at screening and a negative urine pregnancy test on Day -1
- Must be in good health based on medical history, physical examination, vital signs, and 12-lead ECG in the opinion of the investigator at screening.
- Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be ≤1.5x upper limit of normal (ULN) at screening. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
- Negative urine test for selected drugs of abuse (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol (THC), cocaine, opiates, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine [EDDP], tricyclic antidepressants) and alcohol breath test at screening or Day -1
- Negative COVID 19 test (polymerase chain reaction [PCR]) and no clinical symptoms of corona on Day -1
- Willing to adhere to the lifestyle considerations specified in this protocol
Exclusion Criteria
- Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
- Positive serology for hepatitis B virus surface antigen (HBsAg) or anti-hepatitis C virus [HCV] antibodies at screening, or history of hepatitis from any cause except for hepatitis A that was resolved at least 3 months prior to the first IP administration.
- History of or a current immunosuppressive condition, including positive human immunodeficiency virus types 1 or 2 (HIV-1 [2]) antibodies at screening.
- Current or history of vasculitis, valvular heart disease, or large vessel vascular disease (such as aneurism or dissection) at screening.
- Any illness, judged by the investigator as clinically significant, in the 3 months prior to the first IP administration.
- Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate [eGFR] ≤80 mL/min/1.73 m² using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs at screening.
- History of malignancy within the past 5 years prior to screening, except for excised and curatively treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of cervix which is considered cured with minimal risk of recurrence.
- History or presence of clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction, e.g., known long QT syndrome or a QT interval corrected for heart rate according to Fridericia’s formula (QTcF) >450 ms detected on the 12-lead ECG at screening or Day -1. A first-degree atrioventricular block will not be considered as a clinically significant abnormality.
- Significant blood loss (including blood donation [>450 mL]), or transfusion of any blood product within 3 months prior to screening.
- Treatment with any drug known to have a potential for major organ toxicity in the last 3 months before the first IP administration.
- Treatment with any medication (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements), except for occasional use of paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 14 days or 5 half-lives of the drug, whichever is longer, prior to the first IP administration, and the use of hormonal contraceptives in women of childbearing potential and hormonal replacement therapy (HRT) in postmenopausal women.
- Has received or plans to receive any authorized or investigational live vaccine within 4 weeks before the first IP administration. Receipt of vaccines authorized for emergency use (e.g., COVID-19) within the aforementioned timeframe is allowed.
- Concurrent participation or participation in a: - Drug or drug/device study within 30 days or 5 half-lives of the drug (if known by the participant or investigator), whichever is longer, prior to the first IP administration, or - Biologic investigational research study within 3 months or 5 half-lives of the biologic (if known by the participant or investigator), whichever is longer, prior to the first IP administration
- Active drug abuse or alcohol abuse (alcohol abuse defined as regular weekly intake of more than 14 units) within 2 years prior to the first IP administration
- Active smoker and/or has used e-cigarettes, nicotine, or nicotine-containing products (including e-cigarettes or the equivalent of e-cigarettes) within 6 months prior to the first IP administration.
- Regular consumption of a large quantity of any alcohol- or xanthine-containing foods or beverages (caffeine or coffee [>6 cups per day], theine or tea [>6 cups per day], cocoa or chocolate, cola, or energy drinks such as Red Bull etc.) at screening or Day 1
- Investigator or other study staff or relative thereof who is directly involved in the conduct of the study.
- Any condition or circumstances at screening that in the opinion of the investigator could compromise the well being of the participant, may make the participant unlikely or unable to complete the study or comply with study procedures and requirements.
- Have poor venous access that limits blood sampling at screening.
- Any condition that in the opinion of the investigator can be considered as contraindication for MDZ (refer to the SmPC), including but not limited to respiratory conditions and diseases, and acute narrow-angle glaucoma at screening or Day 1.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Not Recruiting | 21 Jun 2023 | 14 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
BUCCOLAM 2.5 mg oromucosal solution | Other | OROMUCOSAL SOLUTION | BUCCAL USE | 2.0 | 4 | PRD8810399 |
BUCCOLAM 2.5 mg oromucosal solution | Other | OROMUCOSAL SOLUTION | BUCCAL USE | 2.0 | 4 | PRD8810529 |
BUCCOLAM 2.5 mg oromucosal solution | Other | OROMUCOSAL SOLUTION | BUCCAL USE | 2.0 | 4 | PRD8810451 |
BUCCOLAM 2.5 mg oromucosal solution | Other | OROMUCOSAL SOLUTION | BUCCAL USE | 2.0 | 4 | PRD8810872 |