Healthy VolunteerPhase 1NCT03205462
An Open Study to Assess the Safety and Pharmacokinetics of Fluorothyazinone as a Single-Dose Administration or a Treatment Course in Healthy Volunteers
A Phase 1 study testing Fluorothyazinone 300 mg, Fluorothyazinone 600 mg and Fluorothyazinone 3900 mg in people with Healthy Volunteer, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
The current Phase I clinical trial has been developed to assess the safety and tolerability of the Fluorothyazinone drug used as a single-dose administration and a treatment course in healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment of volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Fluorothyazinone 300 mg, Fluorothyazinone 600 mg and Fluorothyazinone 3900 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- 10 Aug 2017to 15 Dec 2017
- 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
- - subject is a male or female between the age of 18 - 45 years;
- subject provides written informed consent;
- subject agrees to use effective contraceptive methods during the entire period of participation in the study (one of the following methods will be used: sexual abstinence; condoms (male or female with or without spermicidal agent); diaphragm or cervical cap with spermicidal agent; intrauterine device); in cases where subjects use hormonal contraceptives, their administration should be discontinued at least 2 months prior to the study commencement date;
- body mass index (BMI) of subject: 18.5 ≤ BMI ≤ 30;
- subject has no acute communicable diseases/recurrence of chronic communicable diseases during the participation in the study and 7 days prior to start of the therapy;
- subject has no severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease);
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- in medical history and based on the screening results, subject has no diseases of the gastrointestinal system, liver, kidneys, cardiovascular system, CNS, locomotion system, urogenital and endocrine systems that could affect the assessment of the study results;
- subject has a negative result of the blood or urine pregnancy test (for females of childbearing age) not more than 24 hours prior to receiving the first dose of the studied product;
- subject has negative tests for HIV, hepatitis B and c, syphilis;
- subject has a negative result of the urine test for residual narcotic drugs;
- subject has a negative result of the breath alcohol test;
- subject has no hematopoietic malignancies;
- subject has no malignant neoplasms;
- indicators of clinical biochemical analysis, complete blood count and clinical urine test at a screening visit are within the normal range of reference values*
Who cannot join
- - subject has participated in another clinical trial over the last 90 days;
- subject has experienced symptoms of respiratory disease for the last 3 days;
- subject has received treatment with steroids for the last 10 days (except products for intranasal and topical application);
- subject has received immunoglobulins or other blood products over the last 3 months;
- subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study;
- subject has taken medications that have considerable effects on hemodynamics, liver function, etc. (barbiturates, omeprosole, cimetidine, etc.) within less than 30 days prior to the start of the study;
Show all 17Show fewer
- regular previous or current use of narcotic drugs by subject;
- pregnancy or breast feeding;
- GI system surgeries in subject's history within a one-year period before the subject enters the study;
- subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 90 beats per minute;
- subject has exacerbation of allergic diseases or history of anaphylactic reactions or angioneurotic edema;
- allergic reactions to components of the studied product and concurrent antibacterial agent;
- subject has a concomitant disease which may affect the assessment of the study results: active TB form; chronic hepatic and renal diseases; considerable impairment of thyroid function and other endocrine diseases (diabetes mellitus), severe diseases of the hematopoietic system; epilepsy and other CNS disorders; myocardial infarction in previous history; myocarditis; endocarditis; ischemic heart disease; autoimmune disorders; severe chronic diseases requiring follow-up at the hospital; and, other diseases that, in opinion of the Investigator, will not allow a subject to take part in the study or may affect the study course and/or its results (e.g. assessment of the safety parameters);
- blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study;
- subject has a history of the consumption of more than 5 units (0.25 l of pure alcohol) a week
- subject smokes more than 10 cigarettes a day;
- scheduled hospitalization and/or surgery during the period of participation in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budget-Funded Educational Institution for Additional Professional Education "Russian Medical Academy for Postgraduate Education" of the Ministry of Health of the Russian Federation
Moscow, 123995
About this study
Official title: An Open Study to Assess the Safety and Pharmacokinetics of Fluorothyazinone Used as a Single-Dose Administration or a Treatment Course in Healthy Volunteers
The current Phase I clinical trial has been developed to assess the safety and tolerability of the Fluorothyazinone drug used as a single-dose administration and a treatment course in healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment of volunteers.
Read the detailed description
Based on the screening results of volunteers who signed the Informed Consent Form, the volunteers will be sequentially enrolled in three groups to receive different product doses; the total number of volunteers receiving the product will be not less than 25 individuals. In view of the fact that the product will be studied in humans for the first time, initially 5 volunteers will be admitted to the hospital to receive a single product dose. As soon as the product safety is proven by the follow-up period outcomes on Day 7, the study will be continued with the enrollment of additional 5 volunteers. They will receive a single dose of 600 mg to assess the safety and pharmacokinetics of the studied product.
After the interim safety assessment on Day 7 is completed, additional 15 volunteers will enter the study to receive the product in a dosage regimen proposed for the use in clinical practice.
If necessary, backup individuals (not more than 4) will be additionally enrolled in the study. The original volunteers could be replaced only if they had not received the product; in case where a volunteer has received the product, no replacement will take place.
All volunteers will be divided into three groups. Initially, Group I (5 volunteers) will be included in the study. As soon as the interim results of safety tests (complete blood count, clinical biochemical analysis, clinical urine test and clinical examination of the general state of health) obtained on Day 7 are evaluated, the Investigator will make decision on whether to enroll the second group (5 individuals) to assess the product used in a dose of 600 mg. After the interim safety evaluation on Day 7, additional 15 volunteers will enter the study to receive the product in a dosage regimen proposed for use in clinical practice.
Any of the volunteers who received a dose of the studied product will be considered as a subject enrolled in the study, and his/her data will be used for assessing the product safety and tolerability.
The consecutive enrollment of volunteers is implied for each of the groups with an interim assessment of the safety parameters.
The study will be composed of four (4) visits for volunteers of Group I (a screening visit, the hospitalization visit during which a volunteer will receive the studied product and stay for three (3) days at the hospital, and two outpatient visits - 5 and 7 days after receiving the product).
The study will be composed of four (4) visits for volunteers of Group II (a screening visit, the hospitalization visit during which a volunteer will receive the studied product and stay for seven (7) days at the hospital, and two outpatient visits -14 and 28 days after receiving the product).
The study will be composed of five (5) visits for volunteers of Group III (a screening visit, the hospitalization visit during which a volunteer will receive the studied product and stay for seven (7) days at the hospital, and three outpatient visits - 14, 28 and 60 days after receiving the product).
After a volunteer signs the Informed Consent Form at the screening stage, a screening number will be assigned to the volunteer (consecutive numbering system will be used, i.e. numbers will be assigned to volunteers as they arrive: the first volunteer will be assigned a number 01, the second volunteer - 02, the third - 03, etc.), and appropriate notes will be made in the Case Report Forms (CRF) and source documentation.
- Conditions
- Healthy Volunteer
- Being tested
- Fluorothyazinone 300 mg, Fluorothyazinone 600 mg, Fluorothyazinone 3900 mg
- Keywords
- Pseudomanas Aeruginosa, antibiotic resistance, nosocomial infection, factors of pathogenicity of bacteria, the system of secretion of type III pathogenic bacteria, chronic infection
- Medical subject headings
- Cross Infection, Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorothyazinone 300 mgDrug
Fluorothyazinone in a dosage of 300 mg (1 tablet)
Fluorothyazinone 600 mgDrug
Fluorothyazinone in a dosage of 600 mg (2 tablets) is received per os (oral administration) as a single dose
Fluorothyazinone 3900 mgDrug
The total dose of Fluorothyazinone per treatment course is 3900 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Fluorothyazinone in a dosage of 300 mg (1 tablet) will be administrated to 5 volunteers Receives: Drug: Fluorothyazinone 300 mg |
| Group 2 | Experimental | Fluorothyazinone in a dosage of 600 mg (2 tablets) will be received per os (oral administration) as a single dose Receives: Drug: Fluorothyazinone 600 mg |
| Group 3 | Experimental | on the first day of administration, the product is received according to the following regimen: the first dosage of 60 mg (2 tablets) should be taken orally 30 minutes after meals and swallowed with room-temperature water; the second dosage - 1 tablet (300 mg) - 12 hours later, and then for 5 days the subjects will receive 2 tablets per day. The duration of antibacterial therapy is 6 days. The total dose of Fluorothyazinone per treatment course is 3900 mg. Receives: Drug: Fluorothyazinone 3900 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product safety evaluation by assessing its impact on the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) and clinical laboratory test results in healthy volunteers after administration of the product
To evaluate the product safety by assessing its impact on the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) and clinical laboratory test results in healthy volunteers after administration of the product
Measured: through study completion, an average of 3 month
Secondary outcomes (8)
PK parameters: area under the concentration-time curve from time zero to last measurable concentration in blood sample [AUCo-t]
To assess the pharmacokinetics in healthy volunteers after the product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: area under the concentration-time curve (from time zero to infinity) [AUCo-∞]
To assess the pharmacokinetics in healthy volunteers after product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: the maximum concentration [Cmax]
To assess the pharmacokinetics in healthy volunteers after product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: time to reach the maximum concentration [Tmax]
To assess the pharmacokinetics in healthy volunteers after product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: half-life [T1/2]
To assess the pharmacokinetics in healthy volunteers after product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: elimination rate constant [kel]
To assess the pharmacokinetics in healthy volunteers after product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: volume of distribution [Vd]
To assess the pharmacokinetics in healthy volunteers after product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administratio; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4,Day 5, Day 6
PK parameters: relative rate of absorption [Cmax/AUC]
To assess the pharmacokinetics in healthy volunteers after product administration as a single dose of 600 mg (10 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; Day 3 - 48 hours after the product administration) To assess the pharmacokinetics in healthy volunteers after the product administration as dose 3900 mg (18 time points: Day 1 - prior to the product administration and 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 12 hours after the product administration; Day 2 - 24 and 36 hours after the product administration; 48 hours after the product administration; Day 4 - 71, 74, 83, 86 hours after the product administration; Day 6 - 119, 122, 131 and 134 hours after the product administration.)
Measured: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start10 Aug 2017
- Primary completion8 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The current Phase I clinical trial has been developed to assess the safety and tolerability of the Fluorothyazinone drug used as a single-dose administration and a treatment course in healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment of volunteers
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Pharmaceutical Analytics LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205462
- Sponsor's protocol ID
- 02-FT-2017
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- 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 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Assess the Safety and Pharmacokinetics of Fluorothyazinone Used as a Single-Dose Administration or a Treatment Course in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03205462
- Acronym / sponsor ID
- 02-FT-2017
- Conditions
- Healthy Volunteer
- Keywords
- Pseudomanas Aeruginosa, antibiotic resistance, nosocomial infection, factors of pathogenicity of bacteria, the system of secretion of type III pathogenic bacteria, chronic infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Center of Pharmaceutical Analytics LLC
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 2 Jul 2017 (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.
The current Phase I clinical trial has been developed to assess the safety and tolerability of the Fluorothyazinone drug used as a single-dose administration and a treatment course in healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment of volunteers.
Detailed description
Based on the screening results of volunteers who signed the Informed Consent Form, the volunteers will be sequentially enrolled in three groups to receive different product doses; the total number of volunteers receiving the product will be not less than 25 individuals. In view of the fact that the product will be studied in humans for the first time, initially 5 volunteers will be admitted to the hospital to receive a single product dose. As soon as the product safety is proven by the follow-up period outcomes on Day 7, the study will be continued with the enrollment of additional 5 volunteers. They will receive a single dose of 600 mg to assess the safety and pharmacokinetics of the studied product.
After the interim safety assessment on Day 7 is completed, additional 15 volunteers will enter the study to receive the product in a dosage regimen proposed for the use in clinical practice.
If necessary, backup individuals (not more than 4) will be additionally enrolled in the study. The original volunteers could be replaced only if they had not received the product; in case where a volunteer has received the product, no replacement will take place.
All volunteers will be divided into three groups. Initially, Group I (5 volunteers) will be included in the study. As soon as the interim results of safety tests (complete blood count, clinical biochemical analysis, clinical urine test and clinical examination of the general state of health) obtained on Day 7 are evaluated, the Investigator will make decision on whether to enroll the second group (5 individuals) to assess the product used in a dose of 600 mg. After the interim safety evaluation on Day 7, additional 15 volunteers will enter the study to receive the product in a dosage regimen proposed for use in clinical practice.
Any of the volunteers who received a dose of the studied product will be considered as a subject enrolled in the study, and his/her data will be used for assessing the product safety and tolerability.
The consecutive enrollment of volunteers is implied for each of the groups with an interim assessment of the safety parameters.
The study will be composed of four (4) visits for volunteers of Group I (a screening visit, the hospitalization visit during which a volunteer will receive the studied product and stay for three (3) days at the hospital, and two outpatient visits - 5 and 7 days after receiving the product).
The study will be composed of four (4) visits for volunteers of Group II (a screening visit, the hospitalization visit during which a volunteer will receive the studied product and stay for seven (7) days at the hospital, and two outpatient visits -14 and 28 days after receiving the product).
The study will be composed of five (5) visits for volunteers of Group III (a screening visit, the hospitalization visit during which a volunteer will receive the studied product and stay for seven (7) days at the hospital, and three outpatient visits - 14, 28 and 60 days after receiving the product).
After a volunteer signs the Informed Consent Form at the screening stage, a screening number will be assigned to the volunteer (consecutive numbering system will be used, i.e. numbers will be assigned to volunteers as they arrive: the first volunteer will be assigned a number 01, the second volunteer - 02, the third - 03, etc.), and appropriate notes will be made in the Case Report Forms (CRF) and source documentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The current Phase I clinical trial has been developed to assess the safety and tolerability of the Fluorothyazinone drug used as a single-dose administration and a treatment course in healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment of volunteers
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Fluorothyazinone 300 mgFluorothyazinone in a dosage of 300 mg (1 tablet) will be administrated to 5 volunteers |
| Group 2 | Experimental | Drug: Fluorothyazinone 600 mgFluorothyazinone in a dosage of 600 mg (2 tablets) will be received per os (oral administration) as a single dose |
| Group 3 | Experimental | Drug: Fluorothyazinone 3900 mgon the first day of administration, the product is received according to the following regimen: the first dosage of 60 mg (2 tablets) should be taken orally 30 minutes after meals and swallowed with room-temperature water; the second dosage - 1 tablet (300 mg) - 12 hours later, and then for 5 days the subjects will receive 2 tablets per day. The duration of antibacterial therapy is 6 days. The total dose of Fluorothyazinone per treatment course is 3900 mg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- - subject is a male or female between the age of 18 - 45 years;
- subject provides written informed consent;
- subject agrees to use effective contraceptive methods during the entire period of participation in the study (one of the following methods will be used: sexual abstinence; condoms (male or female with or without spermicidal agent); diaphragm or cervical cap with spermicidal agent; intrauterine device); in cases where subjects use hormonal contraceptives, their administration should be discontinued at least 2 months prior to the study commencement date;
- body mass index (BMI) of subject: 18.5 ≤ BMI ≤ 30;
- subject has no acute communicable diseases/recurrence of chronic communicable diseases during the participation in the study and 7 days prior to start of the therapy;
Key exclusion criteria (17 listed)
- - subject has participated in another clinical trial over the last 90 days;
- subject has experienced symptoms of respiratory disease for the last 3 days;
- subject has received treatment with steroids for the last 10 days (except products for intranasal and topical application);
- subject has received immunoglobulins or other blood products over the last 3 months;
- subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start 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 |
|---|---|---|
| Fluorothyazinone 300 mgFluorothyazinone in a dosage of 300 mg (1 tablet) | Drug | Group 1 |
| Fluorothyazinone 600 mgFluorothyazinone in a dosage of 600 mg (2 tablets) is received per os (oral administration) as a single dose | Drug | Group 2 |
| Fluorothyazinone 3900 mgThe total dose of Fluorothyazinone per treatment course is 3900 mg. | Drug | Group 3 |
Primary outcome
Product safety evaluation by assessing its impact on the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) and clinical laboratory test results in healthy volunteers after administration of the product
Time frame: through study completion, an average of 3 month
To evaluate the product safety by assessing its impact on the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) and clinical laboratory test results in healthy volunteers after administration of the product
8 secondary outcomes
PK parameters: area under the concentration-time curve from time zero to last measurable concentration in blood sample [AUCo-t]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: area under the concentration-time curve (from time zero to infinity) [AUCo-∞]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: the maximum concentration [Cmax]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: time to reach the maximum concentration [Tmax]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: half-life [T1/2]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: elimination rate constant [kel]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
PK parameters: volume of distribution [Vd]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4,Day 5, Day 6
PK parameters: relative rate of absorption [Cmax/AUC]
Time frame: 600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluorothyazinone 300 mg, Fluorothyazinone 600 mg and Fluorothyazinone 3900 mg in people with Healthy Volunteer, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation 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 14 inclusion and 17 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: finished, as of the sponsor's last update on 24 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product safety evaluation by assessing its impact on the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) and clinical laboratory test results in healthy volunteers after administration of the product (time frame: through study completion, an average of 3 month). 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 24 Jul 2018.