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Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706924
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Viriom

Brief Summary:
Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. The study will also assess safety profile of study drugs.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: VM-1500FDC Drug: Elpida® Drug: Truvada® Phase 1

Detailed Description:
The study assesses PK and bioequivalence of the developed new drug VM-1500FDC - a fixed combination of three active substances: elsulfavirine (NNRTI), emtricitabine (NRTI) and tenofovir (NRTI) to Elpida® and Truvada® co-administered. The combination is intended for once daily administration (1 tablet) for the treatment of HIV-1 infection in adult patients. Thus, the purpose of this combination is to simplify the dosage regimen and improve patient compliance

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-Label, Randomized, Parallel-group, Comparative Study of Pharmacokinetics and Bioequivalence of VM-1500FDC (Viriom Ltd, Russia) and Elpida® (Viriom Ltd, Russia) and Truvada® (Gilead Sciences Ireland UC, UK) When сo-administrated Once Daily Fasting in Healthy Subjects
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
Experimental: VM-1500FDC
VM-1500FDC (tenofovir 300 mg/elsulfavirine 20 mg/emtricitabine 200 mg), once daily fasting
Drug: VM-1500FDC
A fixed-dose combination of three active substances: tenofovir 300 mg + elsulfavirine 20 mg + emtricitabine 200 mg, film-coated tablets
Other Name: VM1500FDC

Active Comparator: Elpida® & Truvada®
Elpida®, 20 mg + Truvada® (tenofovir 300 mg / emtricitabine 200 mg), once daily fasting
Drug: Elpida®
Elpida®, capsules, elsulfavirine 20 mg
Other Names:
  • VM-1500
  • VM1500
  • Elsulfavirine

Drug: Truvada®
Truvada® (tenofovir 300 mg / emtricitabine 200 mg), film-coated tablets




Primary Outcome Measures :
  1. Plasma concentration of VM1500A [ Time Frame: 29 days ]
  2. Plasma concentration of elsulfavirine [ Time Frame: 29 days ]
  3. Plasma concentration of emtricitabine [ Time Frame: 29 days ]
  4. Plasma concentration of tenofovir [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. Frequency and severity of AEs and SAEs [ Time Frame: 29 days ]
    Frequency and severity of AE, recorded after administration of the drug according to subjective complaints, changes in vital signs, ECG, laboratory results and physical examination compared to the baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Non-smoking male subjects between the ages of 20 and 40 years (inclusive);
  2. Verified diagnosis of "healthy" according to standard clinical, laboratory and instrumental examination methods;
  3. Body weight from 60 to 95 kg and Body Mass Index from 19.0 to 27.0 kg/m;
  4. A negative result in tests for alcohol and drugs;
  5. The subject's consent to use adequate contraception methods during the study and 3 month after end of study: condom with spermicide (foam, gel, cream, suppositories);
  6. Signed the Participant Explanation Sheet and the Informed Consent Form.

Exclusion Criteria:

  1. Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood;
  2. Variables of standard laboratory and instrumental parameters are beyond the normal limits Variables of standard laboratory and instrumental parameters are beyond the normal limits (taking into account the acceptable limits of laboratory parameters);
  3. Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
  4. Systolic pressure less than 90 mm Mercury or above 130 mm Mercury, diastolic pressure less than 60 mm Mercury or above 85 mm Mercury, heart rate less than 60 BPM or more than 90 BPM at screening;
  5. Regular intake of drugs less than 2 weeks prior to screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 30 days prior to screening;
  6. Presence of antibodies to HIV and hepatitis C virus, presence of hepatitis В surface antigen, a positive syphilis test;
  7. An unstable sleep structure (e.g., night work, sleep disorders, insomnia, recent return from another time zone, etc.), extreme physical activity (e.g. weight lifting), a special diet (e.g. vegetarian, vegan);
  8. Signs of alcohol (taking more than 10 units of alcohol per week ) or drug addiction; alcohol or drugs consumption within 4 days prior to screening; cigarettes smoking 3 months prior to screening; positive drug and/or alcohol test;
  9. Burdened allergic medical history (including drug intolerance and food allergy);
  10. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
  11. Hypersensitivity to tenofovir, elsulfavirine or emtricitabine, as well as any other component of the study drugs;
  12. Blood/plasma donation (450 ml of blood or plasma and more) less than 2 months prior to screening;
  13. Treatment with a study drug in framework of other clinical trials within 30 days prior to screening (including follow-up visits);
  14. Acute infectious diseases less than 4 weeks prior to screening;
  15. Incapable of reading or writing; no desire to understand and adhere to the study protocol procedures; non-compliance with the drugs intake regimen or execution of procedures, which as the Investigator may think may affect the study results or subject's safety and prevent the subject from further participation in the study; any other associated medical or serious psychological conditions making the subject not eligible to participate in the clinical study, restricting legality of obtaining the informed consent or affecting the subject's ability to take part in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706924


Locations
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Russian Federation
Central City Clinical Hospital Reutov
Reutov, Moscow Region, Russian Federation, 143965
Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"
Moscow, Russian Federation, 125315
Sponsors and Collaborators
Viriom
Investigators
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Principal Investigator: Elena Mazygula, PhD Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"
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Responsible Party: Viriom
ClinicalTrials.gov Identifier: NCT03706924    
Other Study ID Numbers: HIV-VM1500FDC-01
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viriom:
HIV -1
elsulfavirine fixed-dose combination
Additional relevant MeSH terms:
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Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents