AzTrials
AzTrials

Viral InfectionNCT05412173

Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers

A study testing Molnupiravir in people with Viral Infection and COVID-19, run by Valenta Pharm JSC at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study aimed for: 1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), based on the analysis of adverse events (AEs); 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?
Molnupiravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteRussia
Study dates
22 Apr 2022to 2 Jun 2022
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

  • Presence of written consent of the volunteer to participate in the study in accordance with applicable law.
  • Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive).
  • Verified diagnosis "healthy": no deviations from the reference values of the data of standard clinical, laboratory and instrumental methods of examination.
  • Systolic blood pressure (SBP) in the range of 110-130 mmHg; diastolic blood pressure (DBP) is 60-85 mmHg).
  • 60-90 bpm at rest for heart rate (HR).
  • 16-20 breaths/min for respiratory rate (RR).
Show all 10Show fewer
  • 35.5 to 36.9°C for body temperature.
  • Body mass index (BMI) within the range of 18.5 ≤ BMI ≤ 30 kg/m2 with a body weight not less than 45 kg for female and not less than 55 kg for male volunteers.
  • The consent of the volunteer (including the partner) to use adequate methods of contraception during the study and 30 days after its completion; for female volunteers - negative blood/urine test result for β-chorionic gonadotropin.
  • Volunteers must behave adequately, coherent speech must be observed.

Who cannot join

  • A history of allergy;
  • A history of drug intolerance to the active and/or excipients in the study drugs;
  • Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary and immune systems, as well as skin, blood and vision;
  • History of gastrointestinal surgery (except appendectomy at least 1 year prior to screening);
  • Diseases/conditions that in the opinion of the investigator may affect the absorption, distribution, metabolism or excretion of the study drugs (drugs);
  • Acute infectious disease less than 4 weeks prior to screening;
Show all 36Show fewer
  • 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 a medicines less than 2 weeks before screening and taking a single medicine less than 7 days before screening;
  • 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 blood/urine β-CGH test for women with 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 330 mL of beer, 150 mL of wine or 40 mL of spirits) in the week in the last month before inclusion in the study or anamnestic evidence of alcoholism, drug addiction, 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;
  • 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, rapid tests of biomaterial (nasopharyngeal and/or oropharyngeal swab) for Severe Acute Respiratory Syndrome Coronavirus 2 antigen (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19);
  • Clinically significant abnormalities on the electrocardiogram (ECG);
  • Positive urinalysis for narcotics and potent drugs;
  • Positive test for the content of alcohol vapor in exhaled air.
  • Scheduling an inpatient stay during the study period, for any reason other than hospitalization required by this protocol.
  • Inability to meet the requirements of the protocol, perform the procedures prescribed in the protocol, follow the diet, activity regimen.
  • Other conditions that, in the opinion of the Investigator, preclude inclusion of the volunteer in the study or may result in early withdrawal of the volunteer from the study, including fasting or a special diet (e.g. vegetarian, vegan, limited table salt) or a special lifestyle (night work, extreme physical activity).
  • Withdrawal criteria:
  • A volunteer withdraws from further participation 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;
  • Volunteer's development of severe adverse event during the study;
  • Missing 2 or more consecutive blood samples or 3 or more blood samples during the same Study Period.
  • Occurrence of vomiting/diarrhea within 6 hours of study drug administration;
  • Positive urine test for narcotics and 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

Other trials in Russia

About this study

Official title: A Randomized, Open-label, Cross-over Adaptive Study of the Comparative Pharmacokinetics and Bioequivalence of the Drugs Molnupiravir, Capsules, 200 mg and Lagevrio, Capsules, 200 mg in Healthy Volunteers at Fasted Conditions

The study aimed for:

  1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), based on the analysis of adverse events (AEs);
  2. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Molnupiravir, capsules, 200 mg (Valenta Pharm JSC, Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), in healthy volunteers in fasted conditions.
Being tested
Molnupiravir
Medical subject headings
Virus Diseases, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MolnupiravirDrug

    A single dose of R or T drug in each of 2 periods of the study in fasted conditions

Study groups in NCT05412173
Study groupRoleWhat they receive
RT-sequenceOtherThe volunteers will take 1 capsule (200 mg) of Lagevrio (R), 200 mg capsules (Merck Sharp \& Dohme (UK) Limited, UK) in Period 1, and 1 capsule (200 mg) of Molnupiravir (T), 200 mg capsules (Valenta Pharm, Russia) in Period 2.
Receives: Drug: Molnupiravir
TR-sequenceOtherThe volunteers will take 1 capsule (200 mg) of the drug Molnupiravir (T), capsules, 200 mg (Valenta Pharm JSC, Russia) in Period 1, and 1 capsule (200 mg) of the drug Lagevrio (R), capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK) in Period 2.
Receives: Drug: Molnupiravir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics - Cmax

    Maximum plasma concentration (Cmax) of β-D-N-4-hydroxycytidine (NHC)

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  2. Pharmacokinetics - tmax

    Time to reach Cmax (tmax) of NHC

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  3. Pharmacokinetics - AUC0-t

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of NHC

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  4. Pharmacokinetics - AUC0-inf

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of NHC

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  5. Pharmacokinetics - AUCextr

    Extrapolated AUC of NHC, defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  6. Pharmacokinetics - t1/2

    Elimination half-life (t1/2) of NHC

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  7. Pharmacokinetics - kel

    Elimination constant (kel) of NHC

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  8. Pharmacokinetics - MRT

    Mean residence time (MRT) of NHC

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  9. Bioequivalence - ratio of Cmax

    Ratio of geometric mean Cmax for NHC after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  10. Bioequivalence - ratio of AUC0-t

    Ratio of geometric mean AUC0-t for NHC after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

  11. Bioequivalence - ratio of AUC0-inf

    Ratio of geometric mean AUC0-inf for NHC after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 24 hours (Day 1-2 and Day 8-9)

Secondary outcomes (48)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. Safety and Tolerability: physical examination results

    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)

  9. Safety and Tolerability: urinalysis - color

    Color of the urine

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  10. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  11. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  12. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  13. Safety and Tolerability: urinalysis - nitrites

    Nitrites in the urine (+/-)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  14. Safety and Tolerability: urinalysis - protein

    Protein in the urine (g/L)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  15. Safety and Tolerability: urinalysis - glucose

    Glucose in the urine (mmol/L)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  16. Safety and Tolerability: urinalysis - ketones

    Ketones in the urine (mmol/L)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  17. Safety and Tolerability: urinalysis - urobilinogen

    Urobilinogen in the urine (mmol/L)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  18. Safety and Tolerability: urinalysis - bilirubin

    Bilirubin in the urine (+/-)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  19. Safety and Tolerability: urinalysis (microscopy) - red blood cells

    Red blood cells in the urine (number in sight)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  20. Safety and Tolerability: urinalysis (microscopy) - white blood cells

    White blood cells in the urine (number in sight)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  21. Safety and Tolerability: urinalysis (microscopy) - cylinders (except hyaline)

    Cylinders (except hyaline) in the urine (number in sight)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  22. Safety and Tolerability: urinalysis (microscopy) - bacteria

    Bacteria in the urine (number in sight)

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  23. Safety and Tolerability: complete blood count - hemoglobin

    Hemoglobin, g/dL

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  24. Safety and Tolerability: complete blood count - red blood cells

    Red blood cells, 10^6/uL

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  25. Safety and Tolerability: complete blood count - hematocrit

    Hematocrit, %

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  26. Safety and Tolerability: complete blood count - platelets

    Platelets, 10^3/uL

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  27. Safety and Tolerability: complete blood count - white blood cells

    White blood cells, 10^3/uL

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  28. Safety and Tolerability: complete blood count - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate, mm per hour

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  29. Safety and Tolerability: complete blood count - neutrophils

    Neutrophils, %

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  30. Safety and Tolerability: complete blood count - lymphocytes

    Lymphocytes, %

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  31. Safety and Tolerability: complete blood count - eosinophils

    Eosinophils, %

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  32. Safety and Tolerability: complete blood count - monocytes

    Monocytes, %

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  33. Safety and Tolerability: complete blood count - basophils

    Basophils, %

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  34. Safety and Tolerability: blood test results - total protein

    Total protein in blood serum, g/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  35. Safety and Tolerability: blood test results - creatinine

    Creatinine in blood serum, umol/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  36. Safety and Tolerability: blood test results - urea

    Urea in blood serum, mmol/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  37. Safety and Tolerability: blood test results - glucose

    Glucose in blood serum, mmol/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  38. Safety and Tolerability: blood test results - total bilirubin

    Total bilirubin in blood serum, umol/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  39. Safety and Tolerability: blood test results - direct bilirubin

    Direct bilirubin in blood serum, umol/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  40. Safety and Tolerability: blood test results - total cholesterol

    Total cholesterol in blood serum, mmol/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  41. Safety and Tolerability: blood test results - triglycerides

    Triglycerides in blood serum, mmol/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  42. Safety and Tolerability: blood test results - alanine transaminase (ALT)

    ALT in blood serum, U/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  43. Safety and Tolerability: blood test results - aspartate transaminase (AST)

    AST in blood serum, U/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  44. Safety and Tolerability: blood test results - alkaline phosphatase (ALP)

    ALP in blood serum, U/L

    Measured: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  45. 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 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  46. 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 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  47. 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 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  48. 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 3, 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.

  1. First posted9 Jun 2022
  2. Study start22 Apr 2022
  3. Primary completion17 May 2022
  4. Study completion2 Jun 2022

Resources

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412173
Sponsor's protocol ID
MOL-05-02-2021
Status last verified
Jul 2023
First submitted
6 Jun 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Molnupiravir in people with Viral Infection and 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 10 inclusion and 36 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: finished, as of the sponsor's last update on 27 Jul 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics - Cmax (time frame: From 0 to 24 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?

On the ClinicalTrials.gov record for NCT05412173.

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 27 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in