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

NCT03709355 | Completed Phase 1 DMC

• 1 other identifier: HIV-VM1500-08
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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®

Conditions

HIV-1-infection

Keywords

HIV-1

Outcome Measures

Primary Outcomes (8)

• Plasma concentration of elsulfavirine

  42 days

• Plasma concentration of VM1500A

  42 days

• Plasma concentration of rifampicin

  42 days

• Plasma concentration of rifabutin

  49 days

• Plasma concentration of clarithromycin

  42 days

• Plasma concentration of atorvastatin

  42 days

• Plasma concentration of levonorgestrel

  42 days

• Plasma concentration of ethinylestradiol

  42 days

Secondary Outcomes (1)

• The incidence of AEs and SAEs

  49 days

Study Arms (8)

Elpida® single dose

ACTIVE COMPARATOR

Single dose of Elpida® (capsule 20 mg)

Drug: Elpida®

Rifampin & Elpida®

EXPERIMENTAL

Single dose of Rifampin (capsule 150 mg), Rifampin + Elpida® 20mg single dose

Drug: Elpida®; Drug: Rifampin

Rifabutin & Elpida®

EXPERIMENTAL

Single dose of Rifabutin capsule 150 mg, Rifabutin + Elpida® 20mg single dose

Drug: Elpida®; Drug: Rifabutin

Clarithromycin & Elpida®

EXPERIMENTAL

Single dose of Clarithromycin capsule 250 mg, Clarithromycin + Elpida® 20mg single dose

Drug: Elpida®; Drug: Clarithromycin

Omeprazole & Elpida®

EXPERIMENTAL

Single dose of Omeprazole capsule 20 mg, Omeprazole + Elpida® 20mg single dose

Drug: Elpida®; Drug: Omeprazole

Atorvastatin & Elpida®

EXPERIMENTAL

Single dose of Atorvastatin tablet 80 mg, Atorvastatin + Elpida® 20mg single dose

Drug: Elpida®; Drug: Atorvastatin

Levonorgestrel+Ethinylestradiol & Elpida®

EXPERIMENTAL

Single dose of Levonorgestrel 150 µg + Ethinylestradiol 150 µg tablet, Levonorgestrel + Ethinylestradiol + Elpida® 20mg single dose

Drug: Elpida®; Drug: Levonorgestrel+Ethinylestradiol

Elpida® multiple dose

ACTIVE COMPARATOR

Elpida® QD dosing for 14 days

Drug: Elpida®

Interventions

Elpida® DRUG

Elpida® capsules, 20mg

Also known as: elsulfavirine, VM1500, VM-1500

Atorvastatin & Elpida®; Clarithromycin & Elpida®; Elpida® multiple dose; Elpida® single dose; Levonorgestrel+Ethinylestradiol & Elpida®; Omeprazole & Elpida®; Rifabutin & Elpida®; Rifampin & Elpida®

Rifampin DRUG

Rifampin capsules, 150mg

Rifampin & Elpida®

Rifabutin DRUG

Rifabutin capsules, 150mg

Rifabutin & Elpida®

Clarithromycin DRUG

Clarithromycin Film-coated tablets, 250mg

Clarithromycin & Elpida®

Omeprazole DRUG

Omeprazole Film-coated tablets 20mg

Omeprazole & Elpida®

Atorvastatin DRUG

Atorvastatin Film-coated tablets, 80mg

Atorvastatin & Elpida®

Levonorgestrel+Ethinylestradiol DRUG

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

Levonorgestrel+Ethinylestradiol & Elpida®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects must meet the following criteria to be enrolled in the study:
• Non-smoking men and women between the ages of 18 and 45 years (inclusive) (only women in Group 7);
• Verified "healthy" diagnosis according to standard clinical, laboratory and instrumental examination methods;
• Body Mass Index ranges between 18.5 kg/m2 and 30.0 kg/m2 and a body weight NLT 50 kg;
• Negative alcohol and drug tests;
• 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;
• Signed Patient Information Sheet and form of Informed Consent to participate in the study.

You may not qualify if:

• A subject will be considered not eligible to participate in the study if one or more of the following criteria is met:
• 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 (taking into account the acceptable limits of laboratory parameters;
• Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
• 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;
• 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;
• 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 (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;
• Drug allergies in medical history (including drug intolerance, including hypersensitivity to any components of study drugs) as well as food allergy;
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Individual intolerance to any components of 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 1 month prior to screening (including follow-up visits);
• Acute infectious diseases less than 4 weeks prior to screening;

Sponsors & Collaborators

• Viriom: lead

Study Sites (1)

Central Clinical City Hospital

Reutov, Moscow Oblast, 143964, Russia

Location

MeSH Terms

Interventions

elsulfavirine; Rifampin; Rifabutin; Clarithromycin; Omeprazole; Atorvastatin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Elena Smolyarchuk, PhD

  I.M. Sechenov First Medical State University

  PRINCIPAL INVESTIGATOR

• Alla Andreeva, PhD

  Smolensk Region Clinical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: November 14, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

RU (1)