CholecystitisPhase 1NCT06315387
Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers
A Phase 1 study testing 4-MUST, 1 tablet, 4-MUST, 2 tablets and 4-MUST, 3 tablets in people with Cholecystitis, run by Valenta Pharm JSC at 1 site in Russia.
Trial summary
Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers 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, 1 tablet, 4-MUST, 2 tablets and 4-MUST, 3 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteRussia
- Study dates
- 4 Dec 2023to 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);
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- Body temperature between 36.0°C and 36.9°C (inclusive);
- Body mass index (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, with body mass ≥ 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.
- Non-inclusion 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 GIT 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 (ID);
- Acute infectious diseases less than 4 weeks prior to screening;
- Taking 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 medication less than 2 weeks prior to screening and a single intake of a medication less than 7 days prior to screening (including over-the-counter medications, 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 medication less than 3 months prior to screening;
- Pregnancy or lactation period; positive urine pregnancy test for women of preserved reproductive potential;
- Women with preserved reproductive potential who have 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;
- Consumption 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 study inclusion or history of alcoholism, drug abuse, or medication abuse;
- Smoking more than 10 cigarettes per day currently, or history of smoking the specified 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 before 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 an inpatient stay during the study period, for any reason other than hospitalization required by this protocol;
- Inability or inability to comply with the requirements of the protocol, to follow the procedures prescribed by the protocol, to observe the diet and activity regimen;
- Vulnerable volunteer population: undergraduate and graduate medical, pharmacy, and dental students, clinical and laboratory assistants, pharmaceutical company employees, military personnel and prisoners, nursing home residents, low-income and unemployed persons, 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 volunteer from being included in the study or could result in the early withdrawal of the volunteer from the study, including fasting or a special diet (e.g., vegetarian, vegan, salt restricted) or a special lifestyle (night work, extreme physical exertion).
Who cannot join
- Withdrawal of the volunteer from further participation 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 serious/severe adverse event in a volunteer during the course of the study;
- Volunteer is receiving or requires treatment that may affect the pharmacokinetics of the study drug;
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- Missing collection of 2 or more consecutive blood samples or 3 or more blood samples during a single Study Period;
- Occurrence of vomiting/diarrhea within 6 h of administration of study drug;
- Positive urine test for narcotics and potent drugs;
- Positive breath alcohol vapor test;
- A positive pregnancy test in women;
- A 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
Limited Liability Company "Medical Center Eco-Safety"
Saint Petersburg, 19119
Vasiliy Vasilyuk, MD,PhD, Prof., +7 (812) 500-52-03 ext. 5001, vasilyuk_vb@ecosafety.ru
About this study
Official title: Open Study of Safety, Tolerability and Pharmacokinetic Parameters of Increasing Doses of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Subsequent Multiple Oral Administration in Healthy Volunteers.
Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers
- Conditions
- Cholecystitis
- Being tested
- 4-MUST, 1 tablet, 4-MUST, 2 tablets, 4-MUST, 3 tablets
- 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, 1 tabletDrug
4-methylumbelliferyl trimebutine sulfate, 128 mg
4-MUST, 2 tabletsDrug
4-methylumbelliferyl trimebutine sulfate, 256 mg
4-MUST, 3 tabletsDrug
4-methylumbelliferyl trimebutine sulfate, 384 mg
| Study group | Role | What they receive |
|---|---|---|
| 4-MUST, 128 mg | Experimental | Single dose: 1 tablet (128 mg). Multiple dose: 1 tablet (128 mg) 3 times a day for 3 days (first dose on an empty stomach, second and third two hours after meals), once in the morning on an empty stomach on day 4. Receives: Drug: 4-MUST, 1 tablet |
| 4-MUST, 256 mg | Experimental | Single dose: 2 tablets (256 mg). Multiple dose: 2 tablets (256 mg) 3 times a day for 3 days (the first intake of the drug on an empty stomach, the second and third - two hours after a meal), once in the morning on an empty stomach on the 4th day. Receives: Drug: 4-MUST, 2 tablets |
| 4-MUST, 384 mg | Experimental | Single dose: 3 tablets (384 mg). Multiple dose: 3 tablets (384 mg) 3 times a day for 3 days (the first intake of the drug on an empty stomach, the second and third - two hours after a meal), once in the morning on an empty stomach on the 4th day. Receives: Drug: 4-MUST, 3 tablets |
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, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - tmax
Time to reach Cmax (tmax) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
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, (single dose); from 0 to 120 hours (multiple dose)
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, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - AUCextr
Extrapolated AUC of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone, defined as (AUC0-inf - AUC0-t)/AUC0-inf
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - t1/2
Elimination half-life (t1/2) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - kel
Elimination constant (kel) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - MRT
Mean residence time (MRT) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - Vd
Volume of distribution of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - CL
Clearance (CL) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Pharmacokinetics - number of terminal timepoints
number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Measured: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
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 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
Adverse event frequency
Number and frequency of adverse events registered during the study
Measured: From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
Adverse event severety
Severity of adverse events registered during the study
Measured: From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
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 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start4 Dec 2023
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT06315387
- Sponsor's protocol ID
- GIB-01-01-2023
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Study of Safety, Tolerability and Pharmacokinetic Parameters of Increasing Doses of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Subsequent Multiple Oral Administration in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT06315387
- Acronym / sponsor ID
- GIB-01-01-2023
- Conditions
- Cholecystitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Mar 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.
Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-MUST, 128 mg | Experimental | Drug: 4-MUST, 1 tabletSingle dose: 1 tablet (128 mg). Multiple dose: 1 tablet (128 mg) 3 times a day for 3 days (first dose on an empty stomach, second and third two hours after meals), once in the morning on an empty stomach on day 4. |
| 4-MUST, 256 mg | Experimental | Drug: 4-MUST, 2 tabletsSingle dose: 2 tablets (256 mg). Multiple dose: 2 tablets (256 mg) 3 times a day for 3 days (the first intake of the drug on an empty stomach, the second and third - two hours after a meal), once in the morning on an empty stomach on the 4th day. |
| 4-MUST, 384 mg | Experimental | Drug: 4-MUST, 3 tabletsSingle dose: 3 tablets (384 mg). Multiple dose: 3 tablets (384 mg) 3 times a day for 3 days (the first intake of the drug on an empty stomach, the second and third - two hours after a meal), once in the morning on an empty stomach on the 4th day. |
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)
- Withdrawal of the volunteer from further participation 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 serious/severe 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, 1 tablet4-methylumbelliferyl trimebutine sulfate, 128 mg | Drug | 4-MUST, 128 mg |
| 4-MUST, 2 tablets4-methylumbelliferyl trimebutine sulfate, 256 mg | Drug | 4-MUST, 256 mg |
| 4-MUST, 3 tablets4-methylumbelliferyl trimebutine sulfate, 384 mg | Drug | 4-MUST, 384 mg |
Primary outcome
Pharmacokinetics - Cmax
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Maximum plasma concentration (Cmax) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - tmax
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Time to reach Cmax (tmax) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - AUC0-t
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
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, (single dose); from 0 to 120 hours (multiple dose)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - AUCextr
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Extrapolated AUC of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone, defined as (AUC0-inf - AUC0-t)/AUC0-inf
Pharmacokinetics - t1/2
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Elimination half-life (t1/2) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - kel
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Elimination constant (kel) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - MRT
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Mean residence time (MRT) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - Vd
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Volume of distribution of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - CL
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
Clearance (CL) of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
Pharmacokinetics - number of terminal timepoints
Time frame: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant of N-desmethyltrimebutin, 4-methylumbelliferone sulfate and 4-methylumbelliferone
4 secondary outcomes
Adverse event type
Time frame: From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
Adverse event frequency
Time frame: From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
Adverse event severety
Time frame: From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
Drop-outs associated with adverse events
Time frame: From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Limited Liability Company "Medical Center Eco-Safety"
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, 1 tablet, 4-MUST, 2 tablets and 4-MUST, 3 tablets 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 18 Mar 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, (single dose); from 0 to 120 hours (multiple dose)). The study lists 11 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 18 Mar 2024.