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

HIV-1-infection Clinical Trial

Official title:

Open-Label Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of ELPIDA® in Co-Administration With Other Drugs in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709355
• Other study ID #: HIV-VM1500-08
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2018
• Est. completion date: September 6, 2019

Study information

• Verified date: January 2022
• Source: Viriom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 ? 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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Elpida®
Elpida® capsules, 20mg
• Rifampin
Rifampin capsules, 150mg
• Rifabutin
Rifabutin capsules, 150mg
• Clarithromycin
Clarithromycin Film-coated tablets, 250mg
• Omeprazole
Omeprazole Film-coated tablets 20mg
• Atorvastatin
Atorvastatin Film-coated tablets, 80mg
• Levonorgestrel+Ethinylestradiol
Levonorgestrel 150 µg + Ethinylestradiol 30 µg, Film-coated tablets

Locations

Country	Name	City	State
Russian Federation	Central Clinical City Hospital	Reutov	Moscow Region

Sponsors (1)

Lead Sponsor	Collaborator
Viriom

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of elsulfavirine		42 days
Primary	Plasma concentration of VM1500A		42 days
Primary	Plasma concentration of rifampicin		42 days
Primary	Plasma concentration of rifabutin		49 days
Primary	Plasma concentration of clarithromycin		42 days
Primary	Plasma concentration of atorvastatin		42 days
Primary	Plasma concentration of levonorgestrel		42 days
Primary	Plasma concentration of ethinylestradiol		42 days
Secondary	The incidence of AEs and SAEs		49 days