Viral Infection COVID-19NCT06096571
Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers
A study testing Aterixen in people with Viral Infection COVID-19, run by Valenta Pharm JSC at 1 site in Russia.
Trial summary
1. Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers, based on AE/SAE (adverse events/serious adverse event) analysis; 2. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Infection COVID-19
- What is being tested?
- Aterixen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
- Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive);
- Verified diagnosis "healthy" (without abnormal findings in the protocol-defined clinical, laboratory, and instrumental test data);
- Blood pressure (BP) levels: 99 to 129 mm Hg, inclusive (systolic, SBP), 70 to 89 mm Hg, inclusive (diastolic, DBP);
- Heart rate (HR) of 60 to 89 bpm, inclusive;
- Respiratory rate (RR) of 12 to 20 breaths per minute, inclusive;
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- Body temperature of 36°C to 36.9°C, inclusive;
- Body mass index (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, where the body weight range is ≥ 55 kg for men and ≥ 45 kg for women;
- Consent to use adequate methods of contraception throughout the study and for 30 days after completion; for women of preserved reproductive potential, a negative urine pregnancy test result.
Who cannot join
- A history of allergy;
- Drug intolerance to the active substance N1-[2-(1-Methyl imidazol-4-yl)-ethyl]perhydroazin-2,6-dione (the active ingredient of Aterixen) and/or excipients contained in the studied drug in the anamnesis;
- History of drug intolerance of N1-[2-(1-Methyl imidazol-4-yl)-ethyl]perhydroazin-2,6-dione (the active ingredient of Aterixen) aand/or excipients contained in the studied drug in the anamnesis;
- History of hereditary galactose intolerance, lactase or glucose-galactose malabsorption
- Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT); disease of the circulatory, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital and the immune systems; dermal, hematopoietic, and ophthalmological diseases;
- History of gastrointestinal surgery (except appendectomy at least 1 year prior to screening);
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- Diseases/conditions that, in the opinion of the investigator, may affect absorption, distribution, metabolism or excretion of the investigational drugs;
- Acute infectious disease less than 4 weeks prior to screening;
- Taking medications that significantly affect hemodynamics and medications that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months prior to screening;
- Regularly taking an medicine less than 2 weeks before screening and taking a single medicine less than 7 days before screening (including OTC medicinal products, vitamins, dietary supplements, or medicinal herbs);
- Donating blood or plasma less than 3 months before screening;
- Use of hormonal contraceptives (in women) less than 2 months before screening;
- The use of depot injections of any drug less than 3 months before screening;
- Pregnancy or lactation; positive urine pregnancy test for women of preserved reproductive potential;
- Women of preserved reproductive potential with a history of unprotected intercourse within 30 days prior to study drug administration with an unsterilized partner;
- Participation in another clinical trial less than 3 months prior to screening or concurrently with the present study;
- Taking more than 10 units of alcohol (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of wine or 50 ml of spirits) a week within a month prior to the enrollment in the study or history data of alcohol/drug dependence or drug abuse;
- Smoking more than 10 cigarettes per day currently, or a history of smoking the specified number of cigarettes during the 6 months prior to screening; disagreement to abstain from smoking for the duration of the hospital stay;
- Consumption of alcohol, caffeine, and xanthine-containing products 7 days prior to the study drug admission;
- Consumption of citrus fruits, cranberries and products containing them, preparations or products containing St. John's wort - 7 days before admission to the study drug;
- Dehydration due to diarrhea, vomiting, or other reason within the last 24 hours prior to study drug administration;
- Positive blood tests for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens at screening;
- Positive rapid test for Coronavirus disease 2019 virus (COVID-19) at screening;
- Clinically significant abnormalities on an electrocardiogram (ECG) history and/or at screening;
- Positive urinalysis for narcotics and powerful drugs at screening;
- Positive breath alcohol vapor test at screening.
- Scheduling an inpatient stay at the time of the study, for any reason other than hospitalization required by this protocol;
- Inability or inability to meet the requirements of the protocol, perform the procedures prescribed by the protocol, follow the diet, activity regimen.
- Belonging to a vulnerable group of volunteers: students of higher and secondary medical, pharmaceutical and dental schools, junior staff of clinics and laboratories, employees of pharmaceutical companies, servicemen and prisoners, persons in nursing homes, low-income and unemployed, national minorities, homeless people, vagrants, refugees, persons under guardianship or custody, and persons unable to give consent, and law enforcement officers;
- Other conditions that, in the opinion of the Researcher, prevent the inclusion of the volunteer in the study or that might lead to early withdrawal of the volunteer from the study, including fasting or a special diet (e.g. vegetarian, vegan, restricted salt intake) or a special lifestyle (night work, extreme physical activity).
- Withdrawal Criteria:
- The volunteer's refusal to further participate in the study;
- Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
- Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
- Volunteers selected for the study in violation of the inclusion/inclusion criteria;
- Development of severe adverse event in the volunteer during the study;
- The volunteer is undergoing or requires treatment that may affect the pharmacokinetic parameters;
- Missing 2 or more consecutive blood samples or 3 or more blood samples during the same Study Period;
- Occurrence of vomiting/diarrhea within 4 hours of study drug administration;
- Positive urine test for narcotics and powerful drugs;
- Positive breath alcohol vapor test.
- Positive pregnancy test in women;
- Positive test for COVID-19;
- The occurrence in the course of the study of other reasons that prevent the study according to the protocol.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, 196143
Vasiliy Vasilyuk, MD, PhD, +7 (901) 304 4248, vasilyuk_vb@ecosafety.ru
About this study
Official title: An Open-label, Randomized, Response-adaptive Crossover Study to Investigate the Comparative Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers
- Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers, based on AE/SAE (adverse events/serious adverse event) analysis;
- Comparative assessment of pharmacokinetic parameters and bioavailability of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.
- To conclude on the bioequivalence of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.
- Conditions
- Viral Infection COVID-19
- Being tested
- Aterixen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AterixenDrug
A single dose of R or T drug in each of 2 periods of the study in fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Experimental: RT-sequence | Other | Group 1 (18 volunteers, RT sequence) will take 1 tablet of Aterixen,100 mg as a single dose in the fasting state in Period 1 and 1 tablet of Aterixen,100 mg film-coated tablet as a single dose in the fasting conditions in Period 2 Receives: Drug: Aterixen |
| Experimental: TR-sequence | Other | Group 2 (18 volunteers, TR sequence) will take 1 tablet of Aterixen,100 mg film-coated tablet as a single dose in the fasting state in Period 1 and 1 tablet of Aterixen,100 mg as a single dose in the fasting conditions in Period 2 Receives: Drug: Aterixen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Pharmacokinetics - tmax
Time to reach Cmax (tmax)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Pharmacokinetics - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Pharmacokinetics - AUCextr
Extrapolated AUC, area under the concentration-time pharmacokinetic curve, to be calculated as Clast/Kel
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Pharmacokinetics - t1/2
Elimination half-life (t1/2)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Pharmacokinetics - Kel
Elimination constant (Kel)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Pharmacokinetics - number of points in terminal logarithmic phase
Used to estimate Kel
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Bioequivalence - ratio of Cmax
Ratio of geometric mean Cmax after intake of R or T (with 90% confidence intervals)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Bioequivalence - ratio of AUC0-t
Ratio of geometric mean AUC0-t after intake of R or T (with 90% confidence intervals)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Bioequivalence - ratio of AUC0-inf
Ratio of geometric mean AUC0-inf after intake of R or T (with 90% confidence intervals)
Measured: From 0 to 12 hours (Day 1-2 and Day 8-9)
Secondary outcomes (43)
Safety and Tolerability: adverse event (AE) number and frequency
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Measured: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: adverse event (AE) characteristics
Description and severity of AEs or serious AEs (SAEs), concomitant therapy for AEs/SAEs, causal relationship, outcomes.
Measured: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
SBP, mmHg
Measured: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
DBP, mmHg
Measured: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - respiratory rate (RR)
RR, breaths per minute
Measured: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - heart rate (HR)
HR, beats per minute
Measured: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - body temperature
Body temperature, centigrade scale
Measured: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: physical examination results
Number of participants with abnormal physical examination results
Measured: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - color
Color of the urine
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - protein
Protein in the urine (g/L)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - glucose
Glucose in the urine (mmol/L)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - red blood cells
Red blood cells in the urine (number in sight)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - white blood cells
White blood cells in the urine (number in sight)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - epithelial cells
Epithelial cells in the urine (number in sight)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - cylinders
Cylinders in the urine (number in sight)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - mucus
Mucus in the urine (presence in sight)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - bacteria
Bacteria in the urine (number in sight)
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - hemoglobin
Hemoglobin, g/dL
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - red blood cells
Red blood cells, 10^6/uL
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - hematocrit
Hematocrit, %
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - platelets
Platelets, 10^3/uL
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - white blood cells
White blood cells, 10^3/uL
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
Erythrocyte sedimentation rate, mm per hour
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - neutrophils
Neutrophils, %
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - lymphocytes
Lymphocytes, %
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - eosinophils
Eosinophils, %
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - monocytes
Monocytes, %
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - basophils
Basophils, %
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - total protein
Total protein in blood serum, g/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - creatinine
Creatinine in blood serum, umol/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - glucose
Glucose in blood serum, mmol/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - total bilirubin
Total bilirubin in blood serum, umol/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - total cholesterol
Total cholesterol in blood serum, mmol/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - alanine transaminase (ALT)
ALT in blood serum, U/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - aspartate transaminase (AST)
AST in blood serum, U/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
ALP in blood serum, U/L
Measured: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Jun 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Infection COVID-19Studies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096571
- Sponsor's protocol ID
- ХС221-05-05-2022
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Response-adaptive Crossover Study to Investigate the Comparative Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06096571
- Acronym / sponsor ID
- ХС221-05-05-2022
- Conditions
- Viral Infection COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers, based on AE/SAE (adverse events/serious adverse event) analysis;
- Comparative assessment of pharmacokinetic parameters and bioavailability of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.
- To conclude on the bioequivalence of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: RT-sequence | Other | Drug: AterixenGroup 1 (18 volunteers, RT sequence) will take 1 tablet of Aterixen,100 mg as a single dose in the fasting state in Period 1 and 1 tablet of Aterixen,100 mg film-coated tablet as a single dose in the fasting conditions in Period 2 |
| Experimental: TR-sequence | Other | Drug: AterixenGroup 2 (18 volunteers, TR sequence) will take 1 tablet of Aterixen,100 mg film-coated tablet as a single dose in the fasting state in Period 1 and 1 tablet of Aterixen,100 mg as a single dose in the fasting conditions in Period 2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
- Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive);
- Verified diagnosis "healthy" (without abnormal findings in the protocol-defined clinical, laboratory, and instrumental test data);
- Blood pressure (BP) levels: 99 to 129 mm Hg, inclusive (systolic, SBP), 70 to 89 mm Hg, inclusive (diastolic, DBP);
- Heart rate (HR) of 60 to 89 bpm, inclusive;
Key exclusion criteria (44 listed)
- A history of allergy;
- Drug intolerance to the active substance N1-[2-(1-Methyl imidazol-4-yl)-ethyl]perhydroazin-2,6-dione (the active ingredient of Aterixen) and/or excipients contained in the studied drug in the anamnesis;
- History of drug intolerance of N1-[2-(1-Methyl imidazol-4-yl)-ethyl]perhydroazin-2,6-dione (the active ingredient of Aterixen) aand/or excipients contained in the studied drug in the anamnesis;
- History of hereditary galactose intolerance, lactase or glucose-galactose malabsorption
- Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT); disease of the circulatory, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital and the immune systems; dermal, hematopoietic, and ophthalmological diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AterixenA single dose of R or T drug in each of 2 periods of the study in fasted conditions | Drug | Experimental: RT-sequence, Experimental: TR-sequence |
Primary outcome
Pharmacokinetics - Cmax
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Maximum plasma concentration (Cmax)
Pharmacokinetics - tmax
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Time to reach Cmax (tmax)
Pharmacokinetics - AUC0-t
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Pharmacokinetics - AUC0-inf
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Pharmacokinetics - AUCextr
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Extrapolated AUC, area under the concentration-time pharmacokinetic curve, to be calculated as Clast/Kel
Pharmacokinetics - t1/2
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Elimination half-life (t1/2)
Pharmacokinetics - Kel
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Elimination constant (Kel)
Pharmacokinetics - number of points in terminal logarithmic phase
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Used to estimate Kel
Bioequivalence - ratio of Cmax
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Ratio of geometric mean Cmax after intake of R or T (with 90% confidence intervals)
Bioequivalence - ratio of AUC0-t
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Ratio of geometric mean AUC0-t after intake of R or T (with 90% confidence intervals)
Bioequivalence - ratio of AUC0-inf
Time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)
Ratio of geometric mean AUC0-inf after intake of R or T (with 90% confidence intervals)
43 secondary outcomes
Safety and Tolerability: adverse event (AE) number and frequency
Time frame: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: adverse event (AE) characteristics
Time frame: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - respiratory rate (RR)
Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - heart rate (HR)
Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: vital signs - body temperature
Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: physical examination results
Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - color
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - transparency
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - pH
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - specific gravity
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - protein
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis - glucose
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - red blood cells
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - white blood cells
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - epithelial cells
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - cylinders
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - mucus
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: urinalysis (microscopy) - bacteria
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - hemoglobin
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - red blood cells
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - hematocrit
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - platelets
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - white blood cells
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - neutrophils
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - lymphocytes
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - eosinophils
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - monocytes
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: complete blood count - basophils
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - total protein
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - creatinine
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - glucose
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - total bilirubin
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Safety and Tolerability: blood test results - total cholesterol
Time frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aterixen in people with Viral Infection COVID-19, run by Valenta Pharm JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Cmax (time frame: From 0 to 12 hours (Day 1-2 and Day 8-9)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.