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

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.

Study Overview

• Status: Recruiting
• Conditions: Biliary Dyskinesia; Chronic Cholecystitis
• Intervention / Treatment: Drug: 4-MUST

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 119991
    • Recruiting
    • I.M. Sechenov First Moscow State Medical University
    • Contact: Elena A Smolyarchuk, MD, PhD; Phone Number: +7 499 248 38 34; Email: smolyarchuk@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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;
• 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)

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AB sequence; 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.	Drug: 4-MUST; 128 mg tablets containing trimebutine 4-methylumbelliferyl sulfate (4-MUST); Other Names: trimebutine 4-methylumbelliferyl sulfate
Experimental: BA sequence; 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.	Drug: 4-MUST; 128 mg tablets containing trimebutine 4-methylumbelliferyl sulfate (4-MUST); Other Names: trimebutine 4-methylumbelliferyl sulfate
Experimental: Multiple dosing; 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).	Drug: 4-MUST; 128 mg tablets containing trimebutine 4-methylumbelliferyl sulfate (4-MUST); Other Names: trimebutine 4-methylumbelliferyl sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - f'	f' - relative bioavailability (AUC(0-t)(fed)/AUC(0- t)(fasting))	From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - f''	f'' is the relative absorption rate (Cmax(fed)/Cmax(fasting))	From 0 to 48 hours (days 1-3 and 8-10)
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	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	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	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	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	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	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	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	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)	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)	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	From 0 to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - hemoglobin	Hemoglobin (g/L)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - hematocrit	Hematocrit (%)	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)	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)	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)	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)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - myelocytes	Leukocyte formula (myelocytes, %)	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, %)	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, %)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - eosinophils	Leukocyte formula (eosinophils, %)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - basophils	Leukocyte formula (basophils, %)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - monocytes	Leukocyte formula (monocytes, %)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: clinical blood test - lymphocytes	Leukocyte formula (lymphocytes, %)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - glucose	Glucose concentration (mmol/L)	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)	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)	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)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: blood chemistry - creatinine	Creatinine concentration (micromol/L)	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)	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)	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)	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	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - color	Color of the urine	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - transparency	Transparency of the urine	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - pH	pH of the urine	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - protein	Protein concentration (g/L)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - glucose	Glucose concentration (mmol/L)	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)	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)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - casts	Presence of casts (Yes/No)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - mucus	Presence of mucus (Yes/No)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Safety and Tolerability: urinalysis - bacteria	Presence of bacteria (Yes/No)	From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Biliary Dyskinesia
• Other Study ID Numbers: GIB-01-05-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No