InfluenzaPhase 1NCT07645534
Safety and Pharmacokinetics of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Compared With Ingavirin, Capsules, 90 mg, Under Fasting and Fed Conditions.
A Phase 1 study testing Ingavirin forte, capsules, 90 mg + 20 mg and Ingavirin, capsules, 90 mg in people with Influenza and Acute Respiratory Viral Infections, run by Valenta Pharm JSC at 1 site in Russia.
Trial summary
This study aims to evaluate the safety and pharmacokinetic profile of the active ingredients Ingavirin forte, capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) relative to single-entity Drug Ingavirin, capsules, 90 mg following administration under fasting and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Acute Respiratory Viral Infections
- What is being tested?
- Ingavirin forte, capsules, 90 mg + 20 mg and Ingavirin, capsules, 90 mg
- 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
- 11 Jul 2025to 31 Dec 2027
- Phase
- Phase 1
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
- Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;
- Males and females aged 18 to 45 years (inclusive);
- Confirmed healthy status, defined as the absence of clinically significant abnormalities based on clinical evaluation, laboratory assessments, and diagnostic procedures as specified in the protocol;
- Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mmHg (inclusive);
- Heart rate (HR) from 60 to 89 beats/min (inclusive);
- Respiratory rate (RR) from 12 to 20 per minute (inclusive);
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- Body temperature from 36.0°C to 36.9°C (inclusive);
- Body mass index (BMI) of 18.5 kg/m² ≤ BMI ≤ 30 kg/m², with body weight for men being ≥ 55 kg and for women ≥ 45 kg;
- Agreement to use adequate methods of contraception throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine β-hCG test result;
- Subjects must demonstrate appropriate behavior and coherent speech;
- Ability to comply with the daily routine and diet prescribed by the study protocol.
- Noninclusion Criteria:
- Clinically significant allergic history;
- History of hypersensitivity to imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or to the excipients contained in the investigational medicinal product;
- History of drug intolerance to imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or to the excipients contained in the investigational medicinal product;
- Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
- Chronic diseases of the kidneys, liver, gastrointestinal (GI) tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary, or immune systems, or of the skin, hematopoietic organs, or eyes;
- History of gastrointestinal (GI) surgical procedures, with the exception of appendectomy performed at least 1 year prior to screening;
- Diseases/conditions that, in the investigator's opinion, may affect the absorption, distribution, metabolism, or excretion of the investigational medicinal product (IMP);
- Acute infectious diseases less than 4 weeks prior to screening;
- Use of medicinal products (MPs) that have a pronounced effect on hemodynamics, MPs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), MPs prolonging the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)) less than 2 months prior to screening;
- Regular use of MPs less than 2 weeks prior to screening and single use of MPs less than 7 days prior to screening (including over-the-counter MPs, vitamins, dietary supplements, herbal medicinal products);
- Donation of blood or plasma less than 3 months prior to screening;
- Use of hormonal contraceptives by womeninitiated less than 2 months prior to the screening visit.
- Use of depot injections of any MPs less than 3 months prior to the start of screening;
- Pregnancy or breastfeeding; positive urine pregnancy test result for women of childbearing potential;
- Women of childbearing potential with a history of unprotected sexual intercourse within 30 days prior to study drug administration with a non-sterilized partner;
- Participation in another clinical trial within 3 months prior to screening or concurrently with the current study.
- Consumption of more than 10 standard alcohol units per week during the month prior to study enrollment, (1 standard unit = 500 mL beer, 200 mL wine, or 50 mL of strong alcoholic beverages), or history of alcoholism, drug dependence, or substance abuse.
- Currently smoking more than 10 cigarettes per day, or a history of smoking the specified number of cigarettes within the 6 months preceding screening; refusal to abstain from smoking while staying at the study center;
- Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to IMP administration;
- Consumption of citrus fruits, cranberries, rose hips and products containing them, or St. John's wort-containing preparations or products within 7 days prior to IMP administration;
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to IMP administration;
- Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus antigens at screening;
- Clinically significant abnormalities on the electrocardiogram (ECG) in the medical history and/or at screening, including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women;
- History of risk factors for torsades de pointes, such as heart failure, hypokalemia, or family history of long QT syndrome;
- Electrolyte imbalances (based on Na+, K+, Cl- levels at screening);
- Positive urine test for narcotic substances and potent medicinal products at screening;
- Positive breath alcohol test at screening;
- Planned hospitalization during the study period for any reason other than hospitalization required by this protocol;
- Inability or incapacity to comply with the protocol requirements, perform protocol-specified procedures, or adhere to the diet and activity restrictions;
- Belonging to a vulnerable group of volunteers: students of higher and secondary medical, pharmaceutical, and dental educational institutions; subordinate clinical or laboratory staff; employees of pharmaceutical companies; military personnel and prisoners; residents of long-term care facilities; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or trusteeship; persons incapable of providing informed consent; as well as law enforcement officers;
- Any other condition which, in the Investigator's judgment, would preclude the subject's enrollment in the study or could lead to premature withdrawal, including adherence to fasting practices or special diets (e.g., vegetarian, vegan, sodium-restricted) or lifestyle factors (e.g., night shift work, extreme physical exertion).
Who cannot join
- Subject's decision to discontinue participation in the study;
- Subject non-compliance with protocol requirements, including but not limited to missed study procedures, unauthorized use of prohibited concomitant medications, or failure to adhere to protocol-defined dietary and lifestyle restrictions.
- Occurrence of any medical condition or safety concern during study participation that could compromise subject safety (e.g., hypersensitivity reactions, etc.);
- Subjects enrolled in the study despite not meeting eligibility criteria (inclusion/exclusion criteria violations).
- Prolongation of the QTcF interval on ECG recording (>500 ms or >60 ms compared to baseline measured on Days 1, 8, 15, and 22);
- Occurrence of a severe adverse event (AE) and/or serious adverse event (SAE) during study participation
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- Missed collection of two or more consecutive blood samples for pharmacokinetic analysis or three or more samples within one pharmacokinetic study period;
- The volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;
- Occurrence of vomiting/diarrhea within 8 hours after administration of the study drug;
- Positive urine test for narcotic substances and potent medicinal products;
- Positive breath alcohol test;
- Positive urine β-hCG test result in women;
- Emergence of any other reason during study participation that, in the Investigator's judgment, precludes the subject's continued compliance with protocol requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal Budgetary Institution of Science "North-West Public Health Research Center"
Saint Petersburg, 191036
Elena Shalukho, MD, +7 (903) 099 57 86, Elena.Shalukho@yandex.ru
About this study
Official title: An Open-Label, Randomized, Crossover Clinical Study to Evaluate the Safety and Pharmacokinetics of the Active Ingredients of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Fixed-Dose Combination Compared With Single-Ingredient Drug Ingavirin, Capsules, 90 mg Under Fasting and Fed Conditions.
This study aims to evaluate the safety and pharmacokinetic profile of the active ingredients Ingavirin forte, capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) relative to single-entity Drug Ingavirin, capsules, 90 mg following administration under fasting and fed conditions.
- Conditions
- Influenza, Acute Respiratory Viral Infections
- Being tested
- Ingavirin forte, capsules, 90 mg + 20 mg, Ingavirin, capsules, 90 mg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingavirin forte, capsules, 90 mg + 20 mgDrug
Also called imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9)
Ingavirin forte containing 90 mg of imidazolylethanamide of pentanedioic acid and 20 mg of N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9)
Ingavirin, capsules, 90 mgDrug
Also called imidazolylethanamide of pentanedioic acid
Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid
| Study group | Role | What they receive |
|---|---|---|
| ACBD sequence | Experimental | ACBD sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. Receives: Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg |
| BADC sequence | Experimental | BADC sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. Receives: Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg |
| CDAB sequence | Experimental | CDAB sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. Receives: Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg |
| DBCA sequence | Experimental | DBCA sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. Receives: Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl] diamide of malonic acid. The same analytes would be used for other pharmacokinetic measures listed below.
Measured: From 0 to 24 hours
Pharmacokinetics - tmax
Time to reach Cmax (tmax)
Measured: From 0 to 24 hours
Pharmacokinetics - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Measured: From 0 to 24 hours
Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: From 0 to 24 hours
Pharmacokinetics - AUCextr
Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Measured: From 0 to 24 hours
Pharmacokinetics - t1/2
Elimination half-life (t1/2)
Measured: From 0 to 24 hours
Pharmacokinetics - kel
Elimination constant (kel)
Measured: From 0 to 24 hours
Pharmacokinetics - number of terminal timepoints
Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
Measured: From 0 to 24 hours
Secondary outcomes (59)
Adverse event type
Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.
Measured: From Screening to Day 29 ± 1
Adverse event number
Number of adverse events registered during the study
Measured: From Screening to Day 29 ± 1
Adverse event severety
Severity of adverse events registered during the study, assessed using the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From Screening to Day 29 ± 1
Discontinuations due to adverse events related to the investigational product
Number of subjects who discontinued the study early due to adverse events (including serious adverse events) related to the investigational product
Measured: From Screening to Day 29 ± 1
Safety and Tolerability: volunteer complaints
Description of any health-related complaints received from volunteer
Measured: From Screening to Day 29 ± 1
Safety and Tolerability: physical examination results - cardiovascular system
An assessment of the condition of the cardiovascular system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/cardiovascular symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: physical examination results - respiratory system
An assessment of the condition of the respiratory system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/respiratory symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: physical examination results - digestive tract
An assessment of the condition of the digestive tract and associated symptoms on physical examination (normal condition or a description of abnormal conditions/digestive tract symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: physical examination results - endocrine system
An assessment of the condition of the endocrine system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/endocrine symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: physical examination results - musculoskeletal system
An assessment of the condition of the musculoskeletal system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/musculoskeletal symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: physical examination results - nervous system
An assessment of the condition of the nervous system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/neurological symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: physical examination results - sensory systems
An assessment of the condition of the sensory systems and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: physical examination results - skin/visible mucous membranes
An assessment of the condition of the skin/visible mucous membranes and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any)
Measured: From Screening to Day 23
Safety and Tolerability: vital signs - systolic blood pressure
Systolic blood pressure (SBP, mmHg)
Measured: From Screening to Day 23
Safety and Tolerability: vital signs - diastolic blood pressure
Diastolic blood pressure (DBP, mmHg)
Measured: From Screening to Day 23
Safety and Tolerability: vital signs - heart rate
Heart rate (HR, bpm)
Measured: From Screening to Day 23
Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)
Body temperature (Celsius temperature scale)
Measured: From Screening to Day 23
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)
Measured: From Screening to Day 23
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)
Measured: From Screening to Day 23
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)
Measured: From Screening to Day 23
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave; Fredericia correction)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - hemoglobin
Hemoglobin (g/L)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - hematocrit
Hematocrit (%)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - red blood cell count
Red blood cell count (cells/L)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - platelet count
Platelet count (cells/L)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - leukocyte count
Leukocyte count (cells/L)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm/h)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - myelocytes
Leukocyte formula (myelocytes, %)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - band neutrophils
Leukocyte formula (band neutrophils, %)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - segmented neutrophils
Leukocyte formula (segmented neutrophils, %)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - eosinophils
Leukocyte formula (eosinophils, %)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - basophils
Leukocyte formula (basophils, %)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - monocytes
Leukocyte formula (monocytes, %)
Measured: From Screening to Day 23
Safety and Tolerability: clinical blood test - lymphocytes
Leukocyte formula (lymphocytes, %)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - color
Color of the urine
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - protein
Protein concentration (g/L)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - glucose
Glucose concentration (mmol/L)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - red blood cells
Red blood cell content (number in sight)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - white blood cells
White blood cell content (number in sight)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - epithelial cells
Epithelial cell content (number in sight)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - casts
Presence of casts (Yes/No)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - mucus
Presence of mucus (Yes/No)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis - bacteria
Presence of bacteria (Yes/No)
Measured: From Screening to Day 23
Safety and Tolerability: urinalysis (microscopy)
Changes in urine sediment parameters (RBCs, WBCs, casts, crystals) as assessed by microscopy
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - glucose
Glucose concentration (mmol/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - cholesterol
Total cholesterol concentration (mmol/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - protein
Total protein concentration (g/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - bilirubin
Total bilirubin concentration (micromol/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - creatinine
Creatinine concentration (micromol/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - alkaline phosphatase
Alkaline phosphatase activity (U/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - alanine transaminase
Alanine transaminase activity (U/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - aspartate transaminase
Aspartate transaminase activity (U/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - potassium concentration
Potassium (mmol/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - sodium concentration
Sodium concentration (mmol/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - chloride concentration
Chloride concentration (mmol/L)
Measured: From Screening to Day 23
Safety and Tolerability: blood chemistry - GFR
Glomerular filtration rate, GFR (mL/min/1,73 м²)
Measured: From Screening to Day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start11 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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 1
- 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
- NCT07645534
- Sponsor's protocol ID
- IFR-01-02-2025
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No