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

NCT03706924 | Completed Phase 1

• 1 other identifier: HIV-VM1500FDC-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV-1-infection

Keywords

HIV -1; elsulfavirine fixed-dose combination

Outcome Measures

Primary Outcomes (4)

• Plasma concentration of VM1500A

  29 days

• Plasma concentration of elsulfavirine

  29 days

• Plasma concentration of emtricitabine

  29 days

• Plasma concentration of tenofovir

  29 days

Secondary Outcomes (1)

• Frequency and severity of AEs and SAEs

  29 days

Study Arms (2)

VM-1500FDC

EXPERIMENTAL

VM-1500FDC (tenofovir 300 mg/elsulfavirine 20 mg/emtricitabine 200 mg), once daily fasting

Drug: VM-1500FDC

Elpida® & Truvada®

ACTIVE COMPARATOR

Elpida®, 20 mg + Truvada® (tenofovir 300 mg / emtricitabine 200 mg), once daily fasting

Drug: Elpida®; Drug: Truvada®

Interventions

VM-1500FDC DRUG

A fixed-dose combination of three active substances: tenofovir 300 mg + elsulfavirine 20 mg + emtricitabine 200 mg, film-coated tablets

Also known as: VM1500FDC

VM-1500FDC

Elpida® DRUG

Elpida®, capsules, elsulfavirine 20 mg

Also known as: VM-1500, VM1500, Elsulfavirine

Elpida® & Truvada®

Truvada® DRUG

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

Elpida® & Truvada®

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking male subjects between the ages of 20 and 40 years (inclusive);
• Verified diagnosis of "healthy" according to standard clinical, laboratory and instrumental examination methods;
• Body weight from 60 to 95 kg and Body Mass Index from 19.0 to 27.0 kg/m;
• A negative result in tests for alcohol and drugs;
• 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);
• Signed the Participant Explanation Sheet and the Informed Consent Form.

You may not qualify if:

• Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood;
• 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);
• Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
• 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;
• 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;
• Presence of antibodies to HIV and hepatitis C virus, presence of hepatitis В surface antigen, a positive syphilis test;
• 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);
• 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;
• Burdened allergic medical history (including drug intolerance and food allergy);
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Hypersensitivity to tenofovir, elsulfavirine or emtricitabine, as well as any other component of the study drugs;
• Blood/plasma donation (450 ml of blood or plasma and more) less than 2 months prior to screening;
• Treatment with a study drug in framework of other clinical trials within 30 days prior to screening (including follow-up visits);
• Acute infectious diseases less than 4 weeks prior to screening;
• 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.

Sponsors & Collaborators

• Viriom: lead

Study Sites (2)

Central City Clinical Hospital Reutov

Reutov, Moscow Oblast, 143965, Russia

Location

Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"

Moscow, 125315, Russia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

elsulfavirine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Elena Mazygula, PhD

  Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: June 1, 2018
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)