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

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ClinicalTrials.gov Identifier: NCT03709355
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Viriom

Brief Summary:
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 or disease Intervention/treatment Phase
HIV-1-infection Drug: Elpida® Drug: Rifampin Drug: Rifabutin Drug: Clarithromycin Drug: Omeprazole Drug: Atorvastatin Drug: Levonorgestrel+Ethinylestradiol Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Elpida®
Single dose of Elpida® (capsule 20 mg)
Drug: Elpida®
Elpida® capsules, 20mg
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • elsulfavirine
  • VM1500
  • VM-1500

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




Primary Outcome Measures :
  1. Plasma concentration of elsulfavirine [ Time Frame: 42 days ]
  2. Plasma concentration of VM1500A [ Time Frame: 42 days ]
  3. Plasma concentration of rifampicin [ Time Frame: 42 days ]
  4. Plasma concentration of rifabutin [ Time Frame: 49 days ]
  5. Plasma concentration of clarithromycin [ Time Frame: 42 days ]
  6. Plasma concentration of atorvastatin [ Time Frame: 42 days ]
  7. Plasma concentration of levonorgestrel [ Time Frame: 42 days ]
  8. Plasma concentration of ethinylestradiol [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. The incidence of AEs and SAEs [ Time Frame: 49 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.

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): 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

Responsible Party: Viriom
ClinicalTrials.gov Identifier: NCT03709355     History of Changes
Other Study ID Numbers: HIV-VM1500-08
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 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:
Omeprazole
Atorvastatin Calcium
Clarithromycin
Rifampin
Rifabutin
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Antibiotics, Antitubercular