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Tests treatment safety and results for Chronic Cholecystitis
Official title Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers
ClinicalTrials.gov ID: NCT07594977
What this study is testing
What is 4-MUST?
4-MUST is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic cholecystitis.
Also referred to as trimebutine 4-methylumbelliferyl sulfate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Voluntary, personally signed ICF obtained prior to any study procedures;
- Males and females aged 18 to 45 years (inclusive) of Caucasian race;
- Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified...
- Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive);
- Heart rate (HR) from 60 to 89 beats/min (inclusive);
You likely can't join if
- Voluntary withdrawal of the subject from the study;
- Failure to comply with protocol requirements by the volunteer (e.g., missing scheduled study procedures, unauthorized use of prohibited medications...
- Occurrence of any event or condition during the study that, in the investigator's judgement, may compromise the volunteer's safety (e.g...
- Volunteers selected for participation in the study in violation of the inclusion/non-inclusion criteria;
- Development of severe adverse event and/or a serious adverse event in a volunteer during the course of the study;
- Volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;
See the full eligibility criteria
Who can join
- Voluntary, personally signed ICF obtained prior to any study procedures;
- Males and females aged 18 to 45 years (inclusive) of Caucasian race;
- Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified in the protocol;
- Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive);
- Heart rate (HR) from 60 to 89 beats/min (inclusive);
- Respiratory rate (RR) from 12 to 20 per 1 minute (inclusive);
- Body temperature from 36.0°C to 36.9°C (inclusive);
- Body mass index (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, with body weight ≥ 55 kg for males and ≥ 45 kg for females;
- Commitment to adhere to highly effective contraceptive methods during the study participation period and for 30 days thereafter; documentation of negative urine pregnancy test for women of childbearing potential. Non
- History of clinically significant allergic reactions;
- Hypersensitivity to hymecromone and trimebutine and/or excipients included in the study drug in anamnesis;
- Drug intolerance to hymecromone and trimebutine and/or excipients included in the study drug in the anamnesis;
- Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption in the anamnesis;
- Chronic diseases of the kidney, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary and immune systems, as well as skin, hematopoietic and...
- History of GI surgery (except for appendectomy at least 1 year prior to screening);
- Diseases/conditions that, in the opinion of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug;
- Acute infectious diseases less than 4 weeks prior to screening;
- Intake of drugs that have a significant effect on hemodynamics and drugs that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;
- Regular intake of a medicine less than 2 weeks prior to screening and single intake of a medicine less than 7 days prior to screening (including over-the-counter medicines, vitamins, supplements, herbs);
- Blood or plasma donation less than 3 months prior to screening;
- Use of hormonal contraceptives (in women) less than 2 months prior to screening;
- Use of depot injections of any medicine less than 3 months prior to screening;
- Pregnancy or lactation period; positive pregnancy test for women of childbearing potential;
- Women of childbearing potential who have had unprotected sexual intercourse with a non-sterilized male partner within 30 days prior to administration of the study drug;
- Participation in another clinical trial less than 3 months prior to screening or concurrent with the present study;
- Consumption of more than 10 units of alcohol per week during the month prior to study enrollment (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine, or 50 mL of spirits), or a history of alcoholism, drug...
- Smoking more than 10 cigarettes per day currently, or a history of smoking the indicated number of cigarettes in the 6 months preceding screening; failure to agree to abstain from smoking for the duration of the...
- Consumption of alcohol, caffeine, and xanthine-containing products in the 7 days prior to taking the study drug;
- Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort - 7 days before taking the study drug;
- Dehydration due to diarrhea, vomiting, or other cause within the last 24 hours prior to taking the study drug;
- Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens at...
- Clinically significant abnormalities on electrocardiogram (ECG) in the medical history and/or at screening;
- Positive urinalysis for narcotics and potent drugs at screening;
- Positive breath alcohol vapor test at screening;
- Scheduling a hospital stay during the study period, for any reason other than hospitalization required by this protocol;
- Failure or inability to comply with protocol requirements, follow protocol procedures, diet and activity regimen.
- Belonging to a vulnerable population, including: students enrolled in medical, pharmaceutical, or dental educational institutions, clinical and laboratory assistants, pharmaceutical company employees, military personnel...
- Any other condition that, in the judgement of the Investigator, would preclude the volunteer's enrollment in the study or could lead to premature withdrawal from the study, including adherence to fasting regimens or...
What rules you out
- Voluntary withdrawal of the subject from the study;
- Failure to comply with protocol requirements by the volunteer (e.g., missing scheduled study procedures, unauthorized use of prohibited medications, or violation of dietary or lifestyle restrictions);
- Occurrence of any event or condition during the study that, in the investigator's judgement, may compromise the volunteer's safety (e.g., hypersensitivity reactions);
- Volunteers selected for participation in the study in violation of the inclusion/non-inclusion criteria;
- Development of severe adverse event and/or a serious adverse event in a volunteer during the course of the study;
- Volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;
- Missing collection of 2 or more consecutive blood samples or 3 x or more blood samples during the same Study Period;
- Occurrence of vomiting/diarrhea within 6 h after administration of study drug;
- Positive urine test for narcotics and potent drugs;
- Positive breath alcohol test;
- Positive pregnancy test in women;
- Occurrence of any other circumstance that precludes conduct of the study in accordance with the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.