Clinical Trials

MainTitle

Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified October 2018 by Viriom

Sponsor
Viriom


Information provided by (Responsible Party)
Viriom
ClinicalTrials.gov Identifier
NCT03709355

First received: October 11, 2018
Last updated: October 15, 2018
Last Verified: October 2018
History of Changes
Purpose

Purpose

The study assesses PK and safety of other drugs, such as some antibiotics, proton pump inhibitors, statins, and combined oral contraceptives when co-administered with Elpida®

Condition Intervention Phase
HIV-1-infection

Drug : Elpida®
Drug : Rifampin
Drug : Rifabutin
Drug : Clarithromycin
Drug : Omeprazole
Drug : Atorvastatin
Drug : Levonorgestrel+Ethinylestradiol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of ELPIDA® in Co-Administration With Other Drugs in Healthy Volunteers

Further study details as provided by Viriom:

Primary Outcome Measures

  • Plasma concentration of elsulfavirine [ Time Frame: 42 days ]
  • Plasma concentration of VM1500A [ Time Frame: 42 days ]
  • Plasma concentration of rifampicin [ Time Frame: 42 days ]
  • Plasma concentration of rifabutin [ Time Frame: 49 days ]
  • Plasma concentration of clarithromycin [ Time Frame: 42 days ]
  • Plasma concentration of atorvastatin [ Time Frame: 42 days ]
  • Plasma concentration of levonorgestrel [ Time Frame: 42 days ]
  • Plasma concentration of ethinylestradiol [ Time Frame: 42 days ]
Secondary Outcome Measures:
  • The incidence of AEs and SAEs [ Time Frame: 49 days ]

Estimated Enrollment: 42
Study Start Date: October 2018
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Elpida®
Single dose of Elpida® (capsule 20 mg)
Drug: Elpida®

Elpida® capsules, 20mg

Other Name:
  • elsulfavirine
  • VM1500
  • VM-1500

Experimental: Rifampin & Elpida®
Single dose of Rifampin (capsule 150 mg), Rifampin + Elpida® 20mg single dose
Drug: Elpida®

Elpida® capsules, 20mg

Other Name:
  • elsulfavirine
  • VM1500
  • VM-1500

Drug: Rifampin

Rifampin capsules, 150mg

Experimental: Rifabutin & Elpida®
Single dose of Rifabutin capsule 150 mg, Rifabutin + Elpida® 20mg single dose
Drug: Elpida®

Elpida® capsules, 20mg

Other Name:
  • elsulfavirine
  • VM1500
  • VM-1500

Drug: Rifabutin

Rifabutin capsules, 150mg

Experimental: Clarithromycin & Elpida®
Single dose of Clarithromycin capsule 250 mg, Clarithromycin + Elpida® 20mg single dose
Drug: Elpida®

Elpida® capsules, 20mg

Other Name:
  • elsulfavirine
  • VM1500
  • VM-1500

Drug: Clarithromycin

Clarithromycin Film-coated tablets, 250mg

Experimental: Omeprazole & Elpida®
Single dose of Omeprazole capsule 20 mg, Omeprazole + Elpida® 20mg single dose
Drug: Elpida®

Elpida® capsules, 20mg

Other Name:
  • elsulfavirine
  • VM1500
  • VM-1500

Drug: Omeprazole

Omeprazole Film-coated tablets 20mg

Experimental: Atorvastatin & Elpida®
Single dose of Atorvastatin tablet 80 mg, Atorvastatin + Elpida® 20mg single dose
Drug: Elpida®

Elpida® capsules, 20mg

Other Name:
  • elsulfavirine
  • VM1500
  • VM-1500

Drug: Atorvastatin

Atorvastatin Film-coated tablets, 80mg

Experimental: Levonorgestrel+Ethinylestradiol & Elpida®
Single dose of Levonorgestrel 150 µg + Ethinylestradiol 150 µg tablet, Levonorgestrel + Ethinylestradiol + Elpida® 20mg single dose
Drug: Elpida®

Elpida® capsules, 20mg

Other Name:
  • elsulfavirine
  • VM1500
  • VM-1500

Drug: Levonorgestrel+Ethinylestradiol

Levonorgestrel 150 μg + Ethinylestradiol 30 μg, Film-coated tablets

Detailed Description:

This study evaluates the drug-drug interaction of Elpida® and other drugs (Rifampin, Rifabutin, Clarithromycin, Omeprazole, Atorvastatin and combinations of Levonorgestrel and Ethinylestradiol) according to changes in the PK parameters of the study substances in their single co-administration in healthy subjects

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:
Healthy subjects must meet the following criteria to be enrolled in the study:

    1. Non-smoking men and women between the ages of 18 and 45 years (inclusive) (only women in Group 7);
    2. Verified "healthy" diagnosis according to standard clinical, laboratory and instrumental examination methods;
    3. Body Mass Index ranges between 18.5 kg/m2 and 30.0 kg/m2 and a body weight NLT 50 kg;
    4. Negative alcohol and drug tests;
    5. Consent to use two adequate and reliable methods of contraception throughout the study and up to 3 months after its completion: a condom with spermicide (foam, gel, cream, suppositories), or a diaphragm with spermicide, or a condom and diaphragm, or a condom and an intrauterine device;
    6. Signed Patient Information Sheet and form of Informed Consent to participate in the study.


Exclusion Criteria:

    A subject will be considered not eligible to participate in the study if one or more of the following criteria is met:
    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 (taking into account the acceptable limits of laboratory parameters;
    3. Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
    4. Systolic pressure below 90 mm Mercury or above 130 mm Mercury, diastolic pressure below 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, hepatic 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 (intake of 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. Drug allergies in medical history (including drug intolerance, including hypersensitivity to any components of study drugs) as well as food allergy;
    10. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
    11. Individual intolerance to any components of 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 1 month prior to screening (including follow-up visits);
    14. Acute infectious diseases less than 4 weeks prior to screening;
    15. Inhibitors or inducers of CYP3A4/5, drugs that cause QT prolongation within 30 days prior to StD administration;
    16. For women - positive result of pregnancy test or breastfeeding; Inability to read or
    write; unwillingness to understand and adhere to the study protocol procedures; non-compliance with the drugs intake regimen or execution of procedures, which as the Investigator believes 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 participate in the study.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03709355

    Contacts

    Contact:   Elena Yakubova, PhD +7 (495) 995-49-44 ey@chemrar.ru
    Contact:   Natalia Vostokova, PhD +7 (495) 995-49-44 nv@ipharma.ru

    Sponsors and Collaborators

    Viriom

    Investigators

    Principal Investigator: Elena Smolyarchuk, PhD I.M. Sechenov First Medical State University
    Principal Investigator: Alla Andreeva, PhD Smolensk Region Clinical Hospital
    More Information

    More Information


    Responsible Party: Viriom  
    ClinicalTrials.gov Identifier: NCT03709355   History of Changes  
    Other Study ID Numbers: HIV-VM1500-08  
    Study First Received: October 11, 2018  
    Last Updated: October 15, 2018  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by Viriom:

    HIV-1

    Additional relevant MeSH terms:
    Clarithromycin
    Rifampin
    Rifabutin
    Omeprazole
    Atorvastatin
    Levonorgestrel
    Ethinyl estradiol, levonorgestrel drug combination
    Ethinyl Estradiol

    ClinicalTrials.gov processed this data on October 15, 2019
    This information is provided by ClinicalTrials.gov.