PharmacodynamicsPhase 1NCT05652595
Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141
A Phase 1 study testing GP40141 and Nplate in people with Pharmacodynamics and Pharmacokinetics, run by Geropharm at 1 site in Russia.
Trial summary
Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamics, Pharmacokinetics, Bioequivalence
- What is being tested?
- GP40141 and Nplate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteRussia
- Study dates
- 3 Jun 2022to 30 Sep 2024
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form. Male aged 18 to 45 years. Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- The level of platelets count (according to the clinical blood test) at screening ranged from the lower threshold of reference values to 306×109/l (inclusive).
- Body mass index between 18,5 and 30 kg/m2, with body weight 60-100 kg Consent to comply with an adequate method of effective contraception throughout the study.
- The consent of volunteers to all restrictions imposed during the study. Russian Federation Citizens
Who cannot join
- History of allergic problems/events. Hypersensitivity to heparin, romiplostim or any of the excipients of the drugs studied or E.coli protein.
- Any acute and chronic diseases, including but not limited to cardiovascular system diseases, bronchopulmonary diseases, neuroendocrine systems diseases, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Positive testing for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum).
- The WHO norms deviations of the heart rate (60-89), Sistolic BP (90-139 mm Hg), Diatolic BP (60-89 mm Hg), respiratory rate (12-20), body temperature (35.7 - 37.0 °C).
- Abnormal ECG during screening. Abnormal results of laboratory methods research. Inaccessible veins of the upper extremities, vein thrombosis, thrombophlebitis in the anamnesis or in the family history of the next of kin, "compromised" veins due to frequent previous venipuncture.
- Surgical interventions on the spleen, splenectomy in anamnesis. Acute infectious diseases in less than 4 weeks before the start of the study. Diseases of the blood, hematopoietic organs and disorders, involving the immune mechanism (ICD-10: D50-D89) in history.
Show all 17Show fewer
- History of arterial and venous thromboses. Presence of malignant (ICD-10: C00-C97) or unknown malignancy of neoplasms (ICD-10: D37-D48), as well as neoplasms in situ (ICD-10: D00-D09) within the last 5 years.
- Regular intake of medications, including vitamins, herbal preparations, and dietary supplements, less than 2 weeks before the start of the study.
- Incomplete recovery from surgery or surgery scheduled for the duration of the subject's participation in the study.
- Significant loss of blood within 3 months prior to screening, including but not limited to blood donation or extended surgery or trauma resulting in the blood loss.
- History of alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
- Positive test results for alcohol or drug use. Nicotine addiction, regular use of tobacco, including all types of electronic cigarettes, less than 6 months prior to screening.
- Participation in a clinical trial of any drugs (including experimental) or experimental medical devices for 3 months or 5 half-lives, whichever is longer, before the study.
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
- Any diet (for example, vegetarian, fasting, etc.) or lifestyle (including night work and extreme physical activity) that may interfere with the study.
- Psychiatric disorders, history of epilepsy and seizures. Taking medications that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before the start of the study.
- Volunteers who are obvious or likely, according to the investigator, are unable to understand and evaluate the information on this study as part of the process of signing informed consent, in particular regarding the expected risks and possible discomfort.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Yaroslavl Region "Clinical Hospital No. 3", ,, Mayakovskogo st., 61
Yaroslavl, 150007
Sergey Noskov, MD, Pr, +74852248854
About this study
Official title: Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141, Powder for Solution for Subcutaneous Administration, 250 µg (GEROPHARM LLC, Russia) and Enplate®, Powder for Solution for Subcutaneous Administration, 250 µg (Amgen Europe B.V. ., Netherlands) in Healthy Volunteers With a Single Subcutaneous Injection
Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.
Read the detailed description
The goal of this study, conducted as a double-blind, randomized, cross-over study of comparative pharmacodynamics and pharmacokinetics, is to compare pharmacodynamics, pharmacokinetics, and safety of drugs containing romiplostim - GP40141 and Nplate® in healthy volunteers after a single subcutaneous injection.
research objectives is:
- Evaluate pharmacodynamic and pharmacokinetic parameters of active ingredients of preparations GP40141 and Enplate®.
- Conduct a comparative analysis of pharmacodynamic and pharmacokinetic parameters of active substances drugs GP40141 and Enplate®.
- Conduct a comparative analysis of data on adverse events (AE) and evaluate immunogenicity after a single subcutaneous administration of GP40141 versus Enplate®. A conclusion about the biosimilarity of drugs will be made by assessing 90% confidence intervals for the ratios of the geometric mean values of the primary pharmacodynamic parameters.
The safety of the compared drugs will be assessed by emergence and development of AE.
- Conditions
- Pharmacodynamics, Pharmacokinetics, Bioequivalence
- Being tested
- GP40141, Nplate
- Keywords
- romiplostim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP40141Drug
Also called romiplostim
Once, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area
NplateDrug
Also called romilostim
Once, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area
| Study group | Role | What they receive |
|---|---|---|
| TR Sequence | Experimental | first Intervention period - subjects are administered test medecine (GP40141) and in seconde Intervention period subjects are administered reference medecine (Nplate) Receives: Drug: GP40141; Drug: Nplate |
| RT Sequence | Experimental | first Intervention period subjects are administered reference medecine (Nplate) and in seconde Intervention period subjects are administered test medecine (GP40141) Receives: Drug: GP40141; Drug: Nplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCplt
the total area under the curve "amount platelets - time" in the time interval from "-45 minutes" to the moment t (day 32 after injection)
Measured: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
Pmax
maximum number of platelets count (any time)
Measured: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
Secondary outcomes (7)
Pmax/P0
ratio: maximum number of platelets count to the basal level of platelets
Measured: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
tPmax
time to reach the maximum number of platelets count
Measured: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
AUC0-t
total area under the curve "concentration of the active substance of the drug - time"
Measured: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
Cmax
blood maximum concentration of the active substance of the drug
Measured: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
Tmax
time to reach the maximum blood concentration (Cmax) of the active substance of the drug
Measured: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
T1/2
half-life of the active substance of the drug
Measured: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
AUC0-∞
total area under the curve "concentration of the active substance of the drug - time" time interval from -15 min to infinity, after the administration of the drug
Measured: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start3 Jun 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacodynamicsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind, randomized, cross-over study of comparative pharmacodynamics and pharmacokinetics
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Igor Mr Makarenko, PhD, Study chair, GEROPHAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652595
- Sponsor's protocol ID
- GP40141-P4-31
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makarenko I, Dorotenko A, Noskov S, Banko V, Saparova V, Khokhlov A, Zoreeva E, Nedorubov A, Zinnatulina B, Gefen M, Drai R. A randomized, double-blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers. Pharmacol Res Perspect. 2023 Oct;11(5):e01125. doi: 10.1002/prp2.1125.
PubMed 37740581
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141, Powder for Solution for Subcutaneous Administration, 250 µg (GEROPHARM LLC, Russia) and Enplate®, Powder for Solution for Subcutaneous Administration, 250 µg (Amgen Europe B.V. ., Netherlands) in Healthy Volunteers With a Single Subcutaneous Injection
- ClinicalTrials.gov ID
- NCT05652595
- Acronym / sponsor ID
- GP40141-P4-31
- Conditions
- Pharmacodynamics, Pharmacokinetics, Bioequivalence
- Keywords
- romiplostim
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 15 Dec 2022 (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.
Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.
Detailed description
The goal of this study, conducted as a double-blind, randomized, cross-over study of comparative pharmacodynamics and pharmacokinetics, is to compare pharmacodynamics, pharmacokinetics, and safety of drugs containing romiplostim - GP40141 and Nplate® in healthy volunteers after a single subcutaneous injection.
research objectives is:
- Evaluate pharmacodynamic and pharmacokinetic parameters of active ingredients of preparations GP40141 and Enplate®.
- Conduct a comparative analysis of pharmacodynamic and pharmacokinetic parameters of active substances drugs GP40141 and Enplate®.
- Conduct a comparative analysis of data on adverse events (AE) and evaluate immunogenicity after a single subcutaneous administration of GP40141 versus Enplate®. A conclusion about the biosimilarity of drugs will be made by assessing 90% confidence intervals for the ratios of the geometric mean values of the primary pharmacodynamic parameters.
The safety of the compared drugs will be assessed by emergence and development of AE.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blind, randomized, cross-over study of comparative pharmacodynamics and pharmacokinetics
| Arm | Type | Receives |
|---|---|---|
| TR Sequence | Experimental | Drug: GP40141, Drug: Nplatefirst Intervention period - subjects are administered test medecine (GP40141) and in seconde Intervention period subjects are administered reference medecine (Nplate) |
| RT Sequence | Experimental | Drug: GP40141, Drug: Nplatefirst Intervention period subjects are administered reference medecine (Nplate) and in seconde Intervention period subjects are administered test medecine (GP40141) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent form. Male aged 18 to 45 years. Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- The level of platelets count (according to the clinical blood test) at screening ranged from the lower threshold of reference values to 306×109/l (inclusive).
- Body mass index between 18,5 and 30 kg/m2, with body weight 60-100 kg Consent to comply with an adequate method of effective contraception throughout the study.
- The consent of volunteers to all restrictions imposed during the study. Russian Federation Citizens
Key exclusion criteria (17 listed)
- History of allergic problems/events. Hypersensitivity to heparin, romiplostim or any of the excipients of the drugs studied or E.coli protein.
- Any acute and chronic diseases, including but not limited to cardiovascular system diseases, bronchopulmonary diseases, neuroendocrine systems diseases, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Positive testing for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum).
- The WHO norms deviations of the heart rate (60-89), Sistolic BP (90-139 mm Hg), Diatolic BP (60-89 mm Hg), respiratory rate (12-20), body temperature (35.7 - 37.0 °C).
- Abnormal ECG during screening. Abnormal results of laboratory methods research. Inaccessible veins of the upper extremities, vein thrombosis, thrombophlebitis in the anamnesis or in the family history of the next of kin, "compromised" veins due to frequent previous venipuncture.
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 |
|---|---|---|
| GP40141Also: romiplostimOnce, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area | Drug | RT Sequence, TR Sequence |
| NplateAlso: romilostimOnce, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area | Drug | RT Sequence, TR Sequence |
Primary outcome
AUCplt
Time frame: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
the total area under the curve "amount platelets - time" in the time interval from "-45 minutes" to the moment t (day 32 after injection)
Pmax
Time frame: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
maximum number of platelets count (any time)
7 secondary outcomes
Pmax/P0
Time frame: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
tPmax
Time frame: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection
AUC0-t
Time frame: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
Cmax
Time frame: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
Tmax
Time frame: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
T1/2
Time frame: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
AUC0-∞
Time frame: -15 min and 1, 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 hour post injection, and additionally 4, 5, 6, 8, 10, 12, 16, 20 days post injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 37740581Makarenko I, Dorotenko A, Noskov S, Banko V, Saparova V, Khokhlov A, Zoreeva E, Nedorubov A, Zinnatulina B, Gefen M, Drai R. A randomized, double-blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers. Pharmacol Res Perspect. 2023 Oct;11(5):e01125. doi: 10.1002/prp2.1125.
- Individual participant dataSharing planned: No
Related trials for Pharmacodynamics
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Igor Mr Makarenko, PhD study chair
GEROPHAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GP40141 and Nplate in people with Pharmacodynamics and Pharmacokinetics, run by Geropharm 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 4 inclusion and 17 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 15 Dec 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Igor Mr Makarenko, PhD (+78124935501 ext. 470, Igor.Makarenko@geropharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCplt (time frame: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection). The study lists 2 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 NCT05652595, which also lists 1 linked publication.
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 15 Dec 2022.