Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers

Recruiting now · Phase 1

Conditions studied: Chronic Cholecystitis, Biliary Dyskinesia

In brief

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.

Key facts

Study ID: NCT07594977
Run by: Valenta Pharm JSC
People needed: 45
Starts: 2026-01-26
Expected to finish: 2027-06-30
Last updated by the study team: 2026-06-15

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify 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 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.
Noninclusion Criteria:
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 visual organs;
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;

You may not qualify 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, 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.

Where it is running

I.M. Sechenov First Moscow State Medical University — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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