Covid19Phase 1NCT05148754

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

A Phase 1 study testing Elsulfavirine in people with Covid19 and HIV-1-infection, run by Viriom at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Covid19, HIV-1-infection
What is being tested?: Elsulfavirine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteRussia
Study dates: 23 Jan 2021to 16 Aug 2021
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

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;

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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.

Who cannot join

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);

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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;
Positive results of urine test for the content of narcotic and potent substances;
Positive urine pregnancy test results in female volunteers;
Any diet, such as a vegetarian diet, within 2 weeks of the first day of screening;
Reception of more than 10 units. alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of wine or 50 ml of strong alcoholic beverages) or history of alcoholism, drug addiction, drug abuse;
Inability to go without food for at least 12 hours and inability to take the drug on an empty stomach;
Donation of blood (450 ml of blood or plasma and more) less than 3 months before the first day of screening;
Depot injections, installation of intrauterine hormonal therapeutic systems or implants of any drugs 6 months before the first day of screening;
For females: use of hormonal contraceptives less than 2 months before the first day of screening;
Regular medicinal drug intake less than 2 weeks before the first day of screening;
Taking medications that have a pronounced effect on hemodynamics, the function of liver microsomal enzymes, the function of the gastrointestinal tract, etc. (barbiturates, omeprazole, cimetidine, etc.), vitamins and or dietary supplements less than 30 days before the first day of screening;
For females: volunteers with preserved reproductive potential who had unprotected intercourse with an unsterilized male partner within 30 days before the first day of screening;
For females: Breast-feeding period
Participation in any other clinical trial or study drug intake less than 3 months before the first day of screening;
Difficulty accessing a vein, making it difficult or impossible to insert a catheter and perform a frequent blood sampling;
Smoking.
Volunteers unwilling or unable to give up alcohol and excessive exercise from the first day of screening to the follow-up visit;
Volunteers who are unwilling or unable to avoid food and drinks containing methylxanthines and grapefruit / grapefruit juice from the first day of screening to the follow-up visit;
Volunteers with lifestyles (including night work and extreme physical activity such as sports or weight lifting) that can make it difficult to interpret laboratory findings from the study;
Volunteers who do not intend to comply with the research regime and / or are not credible to the researcher;
Volunteers who are clearly or likely, in the opinion of the researcher, are not able to understand and evaluate the information on this research as part of the informed consent form signing process, in particular regarding the expected risks and possible discomfort;
Dehydration due to diarrhea, vomiting or other reason within the last 24 hours before the first day of screening;
A history of seizures, epilepsy and any other neurological disorders;
Criteria of exclusion (withdrawn of a volunteer from the study at the initiative of the researcher):
The researcher decided that the volunteer should be excluded in the interests of the volunteer;
Non-compliance with the exclusion criteria identified during the study. Deviations of indicators of vital body functions, as well as standard laboratory and instrumental indicators from the established normal values, detected after the volunteer took the study drug, are considered an undesirable phenomenon;
The occurrence of AEs / SAEs when the continuation of the volunteer's participation in the study is undesirable or impossible (according to the sponsor / manufacturer or researcher);
Vomiting or diarrhea within 8 hours after taking the drug;
Unauthorized concomitant treatment (protocol violation);
Non-compliance by the volunteer with the rules of stay at the clinical base;
The volunteer is receiving additional treatment (or needs additional treatment, including the use of additional drugs) that may affect the pharmacokinetics of the study drugs;
The volunteer requires inpatient treatment during the study;
Volunteers arrive at the hospital later than the appointed time (more than 1 hour late), which violates the protocol requirements;
Positive AOB results;
Positive pregnancy test;
Positive results of urine test for the content of narcotic and potent substances;
In the adverse events that the resulting side effects of the drug are so serious that continuation of the study is unacceptable.
The expulsion of the volunteer at the initiative of the researcher.

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

Other trials in Russia

About this study

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

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

Read the detailed description

The present study is an open-label, single-center, clinical study of the pharmacokinetics and safety of Elsulfavirin 200 mg tablets in four dosage regimens:

Cohort I (N = 3). Single oral dose of 400 mg.
Cohort II (N = 3). Single oral dose of 800 mg.
Cohort III (N = 3). Single oral administration at a dose of 1200 mg.
Cohort IV (N = 6). A single 1200 mg oral dose followed by 200 mg daily for 9 days.

The study is descriptive and will not test any hypotheses. Based on previous studies and the intended descriptive objectives of the study, no control group is planned.

To ensure safety, the following scheme for using the investigational drug is provided:

The inclusion in the study of volunteers included in each subsequent cohort will be carried out strictly after the completion of the study by the last study subject included in the previous cohort and obtaining a safety opinion.
Dosing in the multiple administration cohort will be 2 + 4. Initially, 2 volunteers will be included, after completion of participation, 4 more volunteers will be dosed.

Conditions: Covid19, HIV-1-infection
Being tested: Elsulfavirine
Keywords: Elsulfavirine, HIV-1, 2019-nCoV, SARS-CoV-2
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElsulfavirineDrug
Also called VM-1500
Elsulfavirin 200 mg tablets.

Study groups in NCT05148754
Study group	Role	What they receive
Elsulfavirin 400 mg.	Experimental	Cohort I (N = 3). Single oral dose of 400 mg. Receives: Drug: Elsulfavirine
Elsulfavirin 800 mg.	Experimental	Cohort II (N = 3). Single oral dose of 800 mg. Receives: Drug: Elsulfavirine
Elsulfavirin 1 200 mg.	Experimental	Cohort III (N = 3). Single oral administration at a dose of 1200 mg. Receives: 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. Receives: Drug: Elsulfavirine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 202116 Aug 2021

First posted8 Dec 2021
Study start23 Jan 2021
Primary completion15 Aug 2021
Study completion16 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies 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: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05148754
Sponsor's protocol ID: COVID-VM1500-02
Status last verified: Feb 2021
First submitted: 6 Dec 2021
Last updated: 9 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Clinical Study of the Pharmacokinetics and Safety of Elsulfavirine, 200 mg Tablets, With Single and Multiple Oral Administration in Healthy Volunteers.
ClinicalTrials.gov ID: NCT05148754
Acronym / sponsor ID: COVID-VM1500-02
Conditions: Covid19, HIV-1-infection
Keywords: Elsulfavirine, HIV-1, 2019-nCoV, SARS-CoV-2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: ViriomIndustry (pharma, biotech, devices)
Study start: 23 Jan 2021 (actual)
Primary completion: 15 Aug 2021 (actual)
Study completion: 16 Aug 2021 (actual)
First posted: 8 Dec 2021 (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.

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

Detailed description

The present study is an open-label, single-center, clinical study of the pharmacokinetics and safety of Elsulfavirin 200 mg tablets in four dosage regimens:

Cohort I (N = 3). Single oral dose of 400 mg.
Cohort II (N = 3). Single oral dose of 800 mg.
Cohort III (N = 3). Single oral administration at a dose of 1200 mg.
Cohort IV (N = 6). A single 1200 mg oral dose followed by 200 mg daily for 9 days.

The study is descriptive and will not test any hypotheses. Based on previous studies and the intended descriptive objectives of the study, no control group is planned.

To ensure safety, the following scheme for using the investigational drug is provided:

The inclusion in the study of volunteers included in each subsequent cohort will be carried out strictly after the completion of the study by the last study subject included in the previous cohort and obtaining a safety opinion.
Dosing in the multiple administration cohort will be 2 + 4. Initially, 2 volunteers will be included, after completion of participation, 4 more volunteers will be dosed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Elsulfavirin 400 mg.	Experimental	Drug: ElsulfavirineCohort I (N = 3). Single oral dose of 400 mg.
Elsulfavirin 800 mg.	Experimental	Drug: ElsulfavirineCohort II (N = 3). Single oral dose of 800 mg.
Elsulfavirin 1 200 mg.	Experimental	Drug: ElsulfavirineCohort III (N = 3). Single oral administration at a dose of 1200 mg.
Elsulfavirin 1 200 mg*9	Experimental	Drug: ElsulfavirineCohort IV (N = 6). A single 1200 mg oral dose followed by 200 mg daily for 9 days.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (52 listed)

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;

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
ElsulfavirineAlso: VM-1500Elsulfavirin 200 mg tablets.	Drug	Elsulfavirin 1 200 mg*9, Elsulfavirin 1 200 mg., Elsulfavirin 400 mg., Elsulfavirin 800 mg.

Primary outcome

To evaluate the pharmacokinetics of Elsulfavirine, 200 mg tablets, in healthy volunteers. The incidence of AEs and SAEs.
Time frame: Cohort I-III Not more than 28 days. Cohort IV Not more than 39 days.
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.

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 9 Dec 2021.
Individual participant dataSharing planned: No

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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.

Irina Rodyukova, PhD principal investigator

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

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 Elsulfavirine in people with Covid19 and HIV-1-infection, run by Viriom 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 9 inclusion and 52 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 9 Dec 2021. 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?

To evaluate the pharmacokinetics of Elsulfavirine, 200 mg tablets, in healthy volunteers. The incidence of AEs and SAEs. (time frame: Cohort I-III Not more than 28 days. Cohort IV Not more than 39 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05148754.

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 9 Dec 2021.