An Open Study to Assess the Safety and Pharmacokinetics of Fluorothyazinone as a Single-Dose Administration or a Treatment Course in Healthy Volunteers

NCT03205462 | Completed Phase 1

• 1 other identifier: 02-FT-2017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  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]

  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-∞]

  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]

  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]

  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]

  600 mg - Day 1, Day 2, Day 3; 3900 mg - Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

Study Arms (3)

Group 1

EXPERIMENTAL

Fluorothyazinone in a dosage of 300 mg (1 tablet) will be administrated to 5 volunteers

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

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.

Drug: Fluorothyazinone 3900 mg

Interventions

Fluorothyazinone 300 mg DRUG

Fluorothyazinone in a dosage of 300 mg (1 tablet)

Group 1

Fluorothyazinone 600 mg DRUG

Fluorothyazinone in a dosage of 600 mg (2 tablets) is received per os (oral administration) as a single dose

Group 2

Fluorothyazinone 3900 mg DRUG

The total dose of Fluorothyazinone per treatment course is 3900 mg.

Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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);
• 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\*

You may not qualify if:

• \- 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;
• 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

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Center of Pharmaceutical Analytics LLC: collaborator

Study Sites (1)

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, Russia

Location

MeSH Terms

Conditions

Cross Infection; Persistent Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: August 10, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 15, 2017
• Last Updated: July 24, 2018

Record last verified: 2017-06

Locations

RU (1)