Chronic CholecystitisPhase 1NCT07594977
Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers
A Phase 1 study testing 4-MUST in people with Chronic Cholecystitis and Biliary Dyskinesia, run by Valenta Pharm JSC at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cholecystitis, Biliary Dyskinesia
- What is being tested?
- 4-MUST
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteRussia
- Study dates
- 26 Jan 2026to 30 Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to 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);
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- 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;
- 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 dependence, or abuse of medicinal products;
- 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 hospital stay;
- 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 screening;
- 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 and prisoners, persons residing in residential care facilities, low-income and unemployed, minorities, homeless, vagrants, refugees, persons in foster care, persons unable to consent, and law enforcement officers;
- 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 special diets (e.g., vegetarian, vegan, or sodium-restricted diets) or lifestyle factors (e.g., night-shift work or extreme physical exertion)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
I.M. Sechenov First Moscow State Medical University
Moscow, 119991
Elena A Smolyarchuk, MD, PhD, +7 499 248 38 34, smolyarchuk@mail.ru
About this study
Official title: An Open-Label Study to Evaluate the Effect of Food on the Bioavailability of 4-MUST, 128 mg, Tablets and to Assess the Pharmacokinetics, Safety, and Tolerability Following Single and Multiple Dose Administration in Healthy Volunteers
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.
- Conditions
- Chronic Cholecystitis, Biliary Dyskinesia
- Being tested
- 4-MUST
- Medical subject headings
- Biliary Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-MUSTDrug
Also called trimebutine 4-methylumbelliferyl sulfate
128 mg tablets containing trimebutine 4-methylumbelliferyl sulfate (4-MUST)
| Study group | Role | What they receive |
|---|---|---|
| AB sequence | Experimental | Cohort 1, Group 1 (sequence AB) will receive 3 tablets (384 mg) of the study drug under fasting conditions in Period I and under fed conditions in Period II. Receives: Drug: 4-MUST |
| BA sequence | Experimental | Cohort 1, Group 2 (sequence AB)will receive 3 tablets (384 mg) of the study drug under fed conditions in Period I and under fasting conditions in Period II. Receives: Drug: 4-MUST |
| Multiple dosing | Experimental | Cohort 2, Multiple dose: 3 tablets (384 mg) three times daily, 30 minutes before meals, for 3 consecutive days (with the last dose taken in the morning of Day 4). Receives: Drug: 4-MUST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of 4-MUST metabolites: trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - tmax
Time to reach Cmax (tmax) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - AUC ratio
The ratio of the area under the concentration-time curve over the observation time to the calculated area under the concentration-time curve from zero to infinity
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - t1/2
Elimination half-life (t1/2) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - kel
Elimination constant (kel) of of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - MRT
Mean residence time (MRT) of of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - Vd
Volume of distribution of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - Cmax/AUC0-t
The ratio of the maximum concentration to the area under the concentration-time curve during the observation period
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - f'
f' - relative bioavailability (AUC(0-t)(fed)/AUC(0- t)(fasting))
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - f''
f'' is the relative absorption rate (Cmax(fed)/Cmax(fasting))
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Bioavailability - ratio of Cmax
Ratio of geometric mean Cmax for trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide under fasted and fed conditions (with 90% confidence intervals)
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Bioavailability - ratio of AUC0-t
Ratio of geometric mean AUC0-t for of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide under fasted and fed conditions (with 90% confidence intervals)
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Bioavailability - ratio of AUC0-inf
Ratio of geometric mean AUC0-inf for of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide under fasted and fed conditions (with 90% confidence intervals)
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics (multiple dosing) - number of terminal timepoints
number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant of of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - Cmax
Maximum plasma concentration (Cmax) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - tmax
Time to reach Cmax (tmax) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - AUCextr
Extrapolated AUC of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - t1/2
Elimination half-life (t1/2) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - kel
Elimination constant (kel) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - MRT
Mean residence time (MRT) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - Vd
Volume of distribution of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - CL
Clearance (CL) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 72 to 120 hours
Pharmacokinetics (multiple dosing) - Cmax,ss
Maximum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 72 hours
Pharmacokinetics (multiple dosing) - tmax,ss
Time to reach maximum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 72 hours
Pharmacokinetics (multiple dosing) - tmin,ss
Time to reach minimum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 72 hours
Pharmacokinetics (multiple dosing) - Cmin,ss
Minimum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 72 hours
Pharmacokinetics (multiple dosing) - Cavg,ss
Average plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 72 hours
Pharmacokinetics (multiple dosing) - CL,ss
Clearance at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide
Measured: From 0 to 72 hours
Secondary outcomes (54)
Adverse event type
Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Adverse event frequency
Number and frequency of adverse events registered during the study
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Adverse event severety
Severity of adverse events registered during the study, assessed using the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Drop-outs associated with adverse events
The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - cardiovascular system
An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - respiratory system
An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - digestive tract
An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - endocrine system
An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - musculoskeletal system
An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - nervous system
An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - sensory systems
An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - skin/visible mucous membranes
An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Physical examination results - genitourinary system
An assessment of the condition of the genitourinary system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: vital signs - systolic blood pressure
Systolic blood pressure (SBP, mmHg)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: vital signs - diastolic blood pressure
Diastolic blood pressure (DBP, mmHg)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: vital signs - heart rate
Heart rate (HR, bpm)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: vital signs - respiratory rate
Respiratory rate (breaths per minute)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)
Body temperature (Celsius temperature scale)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6): heart rate (beats per minute)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6): PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QT interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QT interval (distance from the beginning of the QRS complex to the end of the T wave)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - hemoglobin
Hemoglobin (g/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - hematocrit
Hematocrit (%)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - red blood cell count
Red blood cell count (cells/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - platelet count
Platelet count (cells/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - leukocyte count
Leukocyte count (cells/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm/h)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - myelocytes
Leukocyte formula (myelocytes, %)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - band neutrophils
Leukocyte formula (band neutrophils, %)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - segmented neutrophils
Leukocyte formula (segmented neutrophils, %)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - eosinophils
Leukocyte formula (eosinophils, %)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - basophils
Leukocyte formula (basophils, %)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - monocytes
Leukocyte formula (monocytes, %)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - lymphocytes
Leukocyte formula (lymphocytes, %)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - glucose
Glucose concentration (mmol/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - cholesterol
Total cholesterol concentration (mmol/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - total protein
Total protein in blood serum (g/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - bilirubin
Total bilirubin concentration (micromol/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - creatinine
Creatinine concentration (micromol/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - alkaline phosphatase
Alkaline phosphatase activity (U/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - alanine transaminase
Alanine transaminase activity (U/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - aspartate transaminase
Aspartate transaminase activity (U/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - color
Color of the urine
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - protein
Protein concentration (g/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - glucose
Glucose concentration (mmol/L)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - red blood cells
Red blood cell content (number in sight)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - white blood cells
White blood cell content (number in sight)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - casts
Presence of casts (Yes/No)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - mucus
Presence of mucus (Yes/No)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - bacteria
Presence of bacteria (Yes/No)
Measured: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start26 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594977
- Sponsor's protocol ID
- GIB-01-05-2025
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No