NCT03205462

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Fluorothyazinone 300 mg	Fluorothyazinone in a dosage of 300 mg (1 tablet)
DRUG	Fluorothyazinone 600 mg	Fluorothyazinone in a dosage of 600 mg (2 tablets) is received per os (oral administration) as a single dose
DRUG	Fluorothyazinone 3900 mg	The total dose of Fluorothyazinone per treatment course is 3900 mg.

Timeline

• Start date: 2017-08-10
• Primary completion: 2017-12-08
• Completion: 2017-12-15
• First posted: 2017-07-02
• Last updated: 2018-07-24

Locations

1 site across 1 country: Russia