Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers

January 10, 2022 updated by: Viriom

Phase Ib, Single-Center, Randomized Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers

A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women aged 18 to 55 years;
  2. Verified diagnosis "healthy" according to medical history, physical examination, assessment of vital signs, electrocardiography (ECG), investigations performed in the last 14 days prior to the first administration of IP;
  3. Body mass index (BMI) from 18.5 kg/m2 to 30 kg/m2 (inclusive), bodyweight of 50 kg or higher;
  4. Negative result of alcohol and drug tests;
  5. Women must be in postmenopause for at least 2 years, be surgically sterile or use two reliable methods of contraception from the day of screening and until 3 months after the last dose;
  6. Men must use two reliable methods of contraception* from the day of screening and until 3 months after the last dose;
  7. Ability to understand the meaning of the study and any risks associated with participation. Ability to interact with the investigator, participate and comply with the requirements of the study throughout its duration;
  8. Willingness to sign written consent to participate in the study after reading Informed Consent Form with the opportunity to discuss any questions with the investigator (and/or his/her representative).

Exclusion Criteria:

  1. Participation in more than one group of investigational therapy;
  2. Past or present diseases of the cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood that may interfere with achievement of objectives of this study or affect the safety of a volunteer;
  3. The values of laboratory and instrumental parameters, beyond the limit of normal ;
  4. Past or present diseases or pathologies, including surgical interventions in the gastrointestinal tract that, in the opinion of the Investigator, may affect the absorption, distribution, metabolism or excretion of the investigational product;
  5. A systolic pressure of less than 90 mm Hg or greater than 130 mm Hg; diastolic pressure of less than 60 mm Hg or greater than 85 mm Hg; pulse rate of less than 60 bpm or greater than 90 bpm (at screening);
  6. Deviations detected during 12-lead ECG, or QT/QTc interval > 450 milliseconds (ms) for men and > 470 ms for women;
  7. Administration of any drugs n, including over-the-counter products, herbal, food, dietary or vitamin supplements 14 days before the first administration of the investigational product;
  8. Administration of the following drugs for 28 days prior to screening: corticosteroids (any route of administration); IP that inhibit the activity of cytochrome P450 3A4 (CYP3A4; for example, ritonavir and other drugs for human immunodeficiency virus (HIV), ketoconazole, itraconazole, or similar azole antifungals and macrolide antibiotics such as erythromycin), or the use of any drugs with a significant likely effect on functions of organs (for example, barbiturates, omeprazole, cimetidine);
  9. Hepatitis B (HBsAg), antibodies to hepatitis C and HIV, a positive test for syphilis;
  10. Positive pregnancy test (for women);
  11. Acute infectious diseases less than 4 weeks before screening;
  12. Unstable sleeping hours (for example, night shift, sleep disorders, insomnia, jet lag, etc.);
  13. Signs of alcohol or drug addiction; intake of alcohol or drugs 4 days prior to screening and during the study; smoking cigarettes 3 months prior to screening and during the study; positive drug and/or alcohol test;
  14. Complicated allergic history (including intolerance to medication, including hypersensitivity to the active substance/excipients of the investigational drug) and food allergy;
  15. Blood/plasma donation (450 mL of blood or plasma or more) less than 2 months before screening;
  16. Participation in another clinical study or administration of any investigational products less than 3 months before screening;
  17. Any other concomitant medical or significant mental conditions that render a volunteer unsuitable for participation in the clinical study;
  18. A volunteer who is considered for enrollment in the study is an employee of the study site or company of the Sponsor or a member of an employee's family

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Elpida 40 mg once weekly
elsulfavirine 40mg orally once weekly for 8 weeks
Drug: Elpida
elsulfavirine, capsules
Other Names:
  • elsulfavirine
  • VM1500
  • VM-1500
EXPERIMENTAL: Elpida 80 mg once weekly
elsulfavirine 80mg orally once weekly for 8 weeks
Drug: Elpida
elsulfavirine, capsules
Other Names:
  • elsulfavirine
  • VM1500
  • VM-1500
EXPERIMENTAL: Elpida 160 mg once weekly
elsulfavirine 160mg orally once weekly for 8 weeks
Drug: Elpida
elsulfavirine, capsules
Other Names:
  • elsulfavirine
  • VM1500
  • VM-1500

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of AEs and SAEs
Time Frame: 77 days
Incidence of AEs and SAEs
77 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
elsulfavirine plasma concentration
Time Frame: 77 days
elsulfavirine plasma concentration
77 days
VM1500A plasma concentration
Time Frame: 77 days
active metabolite plasma concentration
77 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Viriom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elena Smolyarchuk, MD, PhD, Sechenov First Moscow State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIV-VM1500-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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