CholecystitisPhase 1NCT06342804
Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg
A Phase 1 study testing 4-MUST, 2 tablets, fasted and 4-MUST, 2 tablets, after meals in people with Cholecystitis, run by Valenta Pharm JSC at 1 site in Russia.
Trial summary
Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis
- What is being tested?
- 4-MUST, 2 tablets, fasted and 4-MUST, 2 tablets, after meals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 19 Mar 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
- Males and females between the ages of 18 and 45 years (inclusive) of Caucasian race;
- Verified diagnosis of "healthy" (absence of abnormalities according to the data of clinical, laboratory, instrumental methods of examination stipulated by the protocol);
- Blood pressure (BP) level: 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);
Show all 40Show fewer
- 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;
- Agreement to use adequate contraceptive methods throughout the study and for 30 days after completion of the study, for women of preserved reproductive potential, a negative urine pregnancy test result.
- Noninclusion Criteria:
- Aggravated allergic history;
- Hypersensitivity to gimecromone and trimebutine and/or excipients included in the investigational medicinal product in anamnesis;
- Drug intolerance to hymecromone and trimebutine and/or excipients included in the investigational medicinal product 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;
- A 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 investigational 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 urine pregnancy test for women of preserved reproductive potential;
- Women of preserved reproductive potential with a history of unprotected sexual intercourse within 30 days prior to study medication with an unsterilized partner;
- Participation in another clinical trial less than 3 months prior to screening or concurrent with the present study;
- Intake of more than 10 units of alcohol (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine, or 50 mL of spirits) per week in the last month prior to inclusion in the study or history of alcoholism, drug abuse, or medicine abuse;
- 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;
- Positive result of rapid test for coronavirus disease pathogen 2019 (Coronavirus disease 2019, COVID-19) at screening;
- Clinically significant electrocardiogram (ECG) abnormalities with a 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.
- Vulnerable group of volunteers: medical, pharmacy and dental students, clinical and laboratory assistants, pharmaceutical company employees, military personnel and prisoners, care home residents, low-income and unemployed, minorities, homeless, vagrants, refugees, persons in foster care, persons unable to consent, and law enforcement officers;
- Other conditions that, in the opinion of the Investigator, would preclude the inclusion of the volunteer in the study or could result in early withdrawal of the volunteer from the study, including fasting or a special diet (e.g., vegetarian, vegan, limited table salt) or a special lifestyle (night work, extreme physical exertion).
Who cannot join
- The volunteer refuses to participate in the study;
- Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
- Causes/occurrence of situations during the study that jeopardize the safety of the volunteer (e.g. hypersensitivity reactions, etc.);
- 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;
Show all 13Show fewer
- 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 vapor test;
- A positive pregnancy test in women;
- Positive test for COVID-19;
- Occurrence of other reasons during the study that prevent the conduct of the study according to the protocol.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health"
Saint Petersburg, 191036
Elena S Shalukho, MD, +7 (903) 099 57 86, elena.shalukho@yandex.ru
About this study
Official title: An Open-label Crossover Study With 2 Treatments (Fasting and Fed Conditions), 2 Periods, 2 Sequences to Evaluate the Effect of Food Intake on the Bioavailability of 4-MUST, Tablets, 128 mg at a Single Dose of 256 mg in Healthy Volunteers
Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).
Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).
- Conditions
- Cholecystitis
- Being tested
- 4-MUST, 2 tablets, fasted, 4-MUST, 2 tablets, after meals
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-MUST, 2 tablets, fastedDrug
Also called 4-methylumbelliferyl trimebutine sulfate
2 tablets (256 mg), fasted
4-MUST, 2 tablets, after mealsDrug
Also called 4-methylumbelliferyl trimebutine sulfate
2 tablets (256 mg), after meals
| Study group | Role | What they receive |
|---|---|---|
| AB sequence | Experimental | Group 1 (sequence AB) will take the drug on an empty stomach in Period I and after a meal in Period II Receives: Drug: 4-MUST, 2 tablets, fasted; Drug: 4-MUST, 2 tablets, after meals |
| BA sequence | Experimental | Group 2 (BA sequence) will take the drug after a meal in Period I and on an empty stomach in Period II Receives: Drug: 4-MUST, 2 tablets, fasted; Drug: 4-MUST, 2 tablets, after meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - tmax
Time to reach Cmax (tmax) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
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 N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
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 N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
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 N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - kel
Elimination constant (kel) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - MRT
Mean residence time (MRT) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Pharmacokinetics - Vd
Volume of distribution of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
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 N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone in 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 N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone in 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 N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone in fasted and fed conditions (with 90% confidence intervals)
Measured: From 0 to 48 hours (days 1-3 and 8-10)
Secondary outcomes (4)
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
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start19 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06342804
- Sponsor's protocol ID
- GIB-01-02-2023
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Crossover Study With 2 Treatments (Fasting and Fed Conditions), 2 Periods, 2 Sequences to Evaluate the Effect of Food Intake on the Bioavailability of 4-MUST, Tablets, 128 mg at a Single Dose of 256 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06342804
- Acronym / sponsor ID
- GIB-01-02-2023
- Conditions
- Cholecystitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).
Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB sequence | Experimental | Drug: 4-MUST, 2 tablets, fasted, Drug: 4-MUST, 2 tablets, after mealsGroup 1 (sequence AB) will take the drug on an empty stomach in Period I and after a meal in Period II |
| BA sequence | Experimental | Drug: 4-MUST, 2 tablets, fasted, Drug: 4-MUST, 2 tablets, after mealsGroup 2 (BA sequence) will take the drug after a meal in Period I and on an empty stomach in Period II |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (40 listed)
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
- Males and females between the ages of 18 and 45 years (inclusive) of Caucasian race;
- Verified diagnosis of "healthy" (absence of abnormalities according to the data of clinical, laboratory, instrumental methods of examination stipulated by the protocol);
- Blood pressure (BP) level: 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);
Key exclusion criteria (13 listed)
- The volunteer refuses to participate in the study;
- Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
- Causes/occurrence of situations during the study that jeopardize the safety of the volunteer (e.g. hypersensitivity reactions, etc.);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-MUST, 2 tablets, fastedAlso: 4-methylumbelliferyl trimebutine sulfate2 tablets (256 mg), fasted | Drug | AB sequence, BA sequence |
| 4-MUST, 2 tablets, after mealsAlso: 4-methylumbelliferyl trimebutine sulfate2 tablets (256 mg), after meals | Drug | AB sequence, BA sequence |
Primary outcome
Pharmacokinetics - Cmax
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Maximum plasma concentration (Cmax) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - tmax
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Time to reach Cmax (tmax) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - AUC0-t
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - AUC0-inf
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - AUC ratio
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
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
Pharmacokinetics - t1/2
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Elimination half-life (t1/2) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - kel
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Elimination constant (kel) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - MRT
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Mean residence time (MRT) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - Vd
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Volume of distribution of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - Cmax/AUC0-t
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
The ratio of the maximum concentration to the area under the concentration-time curve during the observation period
Pharmacokinetics - f'
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
f' - relative bioavailability (AUC(0-t)(fed)/AUC(0- t)(fasting))
Pharmacokinetics - f''
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
f'' is the relative absorption rate (Cmax(fed)/Cmax(fasting))
Bioavailability - ratio of Cmax
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Ratio of geometric mean Cmax for N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone in fasted and fed conditions (with 90% confidence intervals)
Bioavailability - ratio of AUC0-t
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Ratio of geometric mean AUC0-t for N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone in fasted and fed conditions (with 90% confidence intervals)
Bioavailability - ratio of AUC0-inf
Time frame: From 0 to 48 hours (days 1-3 and 8-10)
Ratio of geometric mean AUC0-inf for N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone in fasted and fed conditions (with 90% confidence intervals)
4 secondary outcomes
Adverse event type
Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Adverse event frequency
Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Adverse event severety
Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Drop-outs associated with adverse events
Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Cholecystitis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Recruiting
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Cholelithiasis, Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health"
Saint Petersburg, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4-MUST, 2 tablets, fasted and 4-MUST, 2 tablets, after meals in people with Cholecystitis, run by Valenta Pharm JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Cmax (time frame: From 0 to 48 hours (days 1-3 and 8-10)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.