An Open-label Clinical Study of the Pharmacokinetics and Safety of Elsulfavirine, 200 mg Tablets, With Single and Multiple Oral Administration in Healthy Volunteers

NCT05148754 | Completed Phase 1

• 1 other identifier: COVID-VM1500-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label clinical study of the pharmacokinetics and safety of Elsulfavirine, 200 mg tablets, with single and multiple oral administration in healthy volunteers.

Conditions

Covid19; HIV-1-infection

Keywords

Elsulfavirine; HIV-1; 2019-nCoV; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetics of Elsulfavirine, 200 mg tablets, in healthy volunteers. The incidence of AEs and SAEs.

  To evaluate the pharmacokinetics of Elsulfavirine, 200 mg tablets, in healthy volunteers. Describe and study the pharmacokinetic parameters and relative bioavailability of the study drug for different modes of administration. Conduct an assessment and comparative analysis of the safety and tolerability of the study drug based on data on adverse events.

  Cohort I-III Not more than 28 days. Cohort IV Not more than 39 days.

Study Arms (4)

Elsulfavirin 400 mg.

EXPERIMENTAL

Cohort I (N = 3). Single oral dose of 400 mg.

Drug: Elsulfavirine

Elsulfavirin 800 mg.

EXPERIMENTAL

Cohort II (N = 3). Single oral dose of 800 mg.

Drug: Elsulfavirine

Elsulfavirin 1 200 mg.

EXPERIMENTAL

Cohort III (N = 3). Single oral administration at a dose of 1200 mg.

Drug: Elsulfavirine

Elsulfavirin 1 200 mg*9

EXPERIMENTAL

Cohort IV (N = 6). A single 1200 mg oral dose followed by 200 mg daily for 9 days.

Drug: Elsulfavirine

Interventions

Elsulfavirine DRUG

Elsulfavirin 200 mg tablets.

Also known as: VM-1500

Elsulfavirin 1 200 mg*9; Elsulfavirin 1 200 mg.; Elsulfavirin 400 mg.; Elsulfavirin 800 mg.

Eligibility Criteria

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

You may qualify if:

• Male and female between the ages of 18 and 45 years (inclusive).
• Body mass index in the range of 18.6-29.9 kg / m 2 inclusive;
• Verified diagnosis medically fit according to the data from standard clinical, laboratory and instrumental examination methods;
• Systolic blood pressure is not less than 100 mm hg and not higher than 130 mm hg ; diastolic blood pressure not less than 60 mm hg and not higher than 90 mm hg; pulse rate not less than 60 beats / min and not more than 90 beats / min, respiratory rate within 12-20 per minute; body temperature not less than 35.9 ° С and not more than 36.9 ° С.
• The ability to understand and comprehend the explanation about the research;
• Willingness to comply with all procedures and restrictions associated with research;
• The written informed consent of the volunteer to participate in the study in accordance with the current legislation, obtained before the start of any research procedures;
• For women with preserved reproductive potential - a negative pregnancy test and consent to adhere to adequate contraceptive methods from the screening visit up to 180 days after the last intake of the study drug, inclusively, or lack of reproductive potential;
• For men - consent to adhere to adequate contraceptive methods with partners with preserved reproductive potential from the first day of screening to 180 days after the last dose of the study drug, inclusive.

You may not qualify if:

• A volunteer will not be included in the study if at least one of the following criteria is met:
• Drug intolerance to any drug;
• Relevant history of allergies
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Acute infectious diseases or allergic reactions requiring treatment (including drug allergies) less than 4 weeks before the first day of screening;
• Surgical interventions on the gastrointestinal tract (except appendectomy);
• Volunteers with suspected hypersensitivity to study drugs or any of their components;
• Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood or other conditions that make it impossible for a volunteer to participate in the study, according to the researcher;
• The results of standard laboratory and instrumental examination tests obtained during the screening, which go beyond the normal values;
• A positive result for at least one of the following tests:
• blood test for HIV;
• blood test for Syphilis;
• blood test for hepatitis B;
• blood test for hepatitis C;
• Positive AOB results;

Sponsors & Collaborators

• Viriom: lead

Study Sites (1)

State Budgetary Institution Healthcare of the City of Moscow " V. P. Demikhov City Clinical Hospital of the Department of Healthcare of the City of Moscow"

Moscow, 109263, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

elsulfavirine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Irina Rodyukova, PhD

  V. P. Demikhov City Clinical Hospital of the Department of Healthcare of the City of Moscow

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 8, 2021
• Study Start: January 23, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 16, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)