PharmacokineticsPhase 1NCT06497049
Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.
A Phase 1 study testing GP40221 and ozempic in people with Pharmacokinetics and Safety Issues, run by Geropharm at 1 site in Russia.
Trial summary
Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers. 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
- Pharmacokinetics, Safety Issues, Bioequivalence
- What is being tested?
- GP40221 and ozempic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jun 2023to 5 May 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 to participate in the study.
- Males with a verified diagnosis "healthy" according to the data of standard clinical, laboratory and instrumental examination methods.
- Age 18-45 years old inclusive.
- Body mass index 18.5 - 29.9 kg/m2.
- Agree to use an adequate method of contraception (double barrier method) during the entire period of participation in the study and for 3 weeks after its completion.
- Consent to all restrictions imposed during the study.
- Citizenship of the Russian Federation.
Who cannot join
- Burdened allergic history, drug intolerance.
- Hypersensitivity to heparin, semaglutide and any of the excipients of the study drug.
- Any acute and chronic diseases, incl. but not limited to:
- diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract (including diseases of the colon), liver, kidneys, blood;
- positive test results for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum).
- Deviations from normal values of heart rate (60-80), SBP (100-130 mm Hg), DBP (60-85 mm Hg), NPV (16-20), body temperature (35.7 - 37.0 °C).
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- ECG Deviations, according to a specialist, during screening.
- laboratory tests results deviations from the normal values.
- Hard-to-reach veins of the upper extremities, vein thrombosis, thrombophlebitis in a family history of close relatives, "compromised" veins due to frequent previous venipunctures.
- Surgical interventions on the gastrointestinal tract (with the exception of appendectomy) in history.
- Acute infectious diseases less than 4 weeks prior to screening.
- History of medullary thyroid cancer and/or multiple endocrine neoplasia type 2, including family history.
- History of chronic or acute pancreatitis.
- Regular use of any prescription and over-the-counter medications (in particular drugs that reduce heart rate), dietary supplements, vitamins less than 2 weeks before the start of screening, taking St. John's wort (Hypericum perforatum) less than 30 days before the start screening.
- Use of semaglutide or other analogues of human glucagon-like peptide-1 (GLP-1) within 6 months before screening.
- Use of depot injections or implants of any medications 3 months before the start of screening.
- Significant blood loss (more than 450 ml of blood or plasma) within 3 months prior to screening, due to, including, but not limited to, blood donation, blood loss during advanced surgery or trauma.
- Drinking alcohol in quantities exceeding 10 units per week (on average) (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of dry wine or 50 ml of strong alcoholic drinks) or anamnestic information about alcoholism, drug addiction, abuse of strong drugs.
- Positive test results for alcohol, drug use and the use of strong drugs.
- Nicotine addiction (regular tobacco use, including smoking of all types of electronic cigarettes, hookahs, snuff, etc. less than 6 months prior to screening).
- Participation in a clinical trial of any drugs (including experimental drugs) or experimental medical devices for 3 months or 5 half-lives prior to Screening, whichever is longer.
- Any diet (eg vegetarian, fasting, etc.) or lifestyle (including night work and extreme physical activity such as heavy lifting) that may interfere with the study.
- Taking drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before screening.
- Consumption of citrus fruits (including grapefruit and grapefruit juice), cranberries (juice, fruit drink, etc.), starfruit or pomelo 14 days before the start of screening.
- Incomplete recovery from surgery or surgery scheduled while the volunteer was participating in the study.
- Other diseases/conditions that, in the opinion of the researcher, may affect the pharmacokinetics of the active substance of the drugs or increase the risk to the health of the volunteer.
- Tattoos or piercings less than 30 days before screening.
- Volunteers who are obviously or likely, in the opinion of the investigator, unable to understand and evaluate the information on this study as part of the informed consent process, in particular regarding expected risks and possible discomfort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221, Solution for Subcutaneous Administration 1.34 mg/ml (GEROPHARM) and Ozempic®, Solution for Subcutaneous Administration 1.34 mg/ml in Healthy Volunteers
Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.
- Conditions
- Pharmacokinetics, Safety Issues, Bioequivalence
- Being tested
- GP40221, ozempic
- Keywords
- semaglutide, ozempic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP40221Drug
Also called semaglutide
Solution for Subcutaneous Administration 1.34 mg/ml
ozempicDrug
Also called semaglutide
Solution for Subcutaneous Administration 1.34 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| GP40221 | Experimental | GP40221 is administered subcutaneously into the subcutaneous fat of the anterior abdominal wall at a dose of 0.5 mg using a pen injector. Receives: Drug: GP40221 |
| ozempic | Active comparator | Ozempic® is administered subcutaneously into the subcutaneous fat of the anterior abdominal wall at a dose of 0.5 mg using a pen injector Receives: Drug: ozempic |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-t
Total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to the collection of the last blood sample with a determined concentration of the active substance at time point t
Measured: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Cmax
Maximum concentration of the active substance in the blood plasma of volunteers during the observation period
Measured: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Secondary outcomes (4)
tmax
Time to reach the maximum concentration (Cmax) of an active substance in the blood plasma of volunteers
Measured: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
t1/2
half-life of an active substance
Measured: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
λz
constant of elimination of an active substance
Measured: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
AUC0-∞
total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to infinity
Measured: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start30 Jun 2023
- Primary completion5 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open randomized study of comparative pharmacokinetics and biosimilarity of GP40221, solution for subcutaneous administration, 1.34 mg/ml and Ozempic®, solution for subcutaneous administration, 1.34 mg/ml in parallel groups in healthy volunteers
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergei Noskov, MD, Pr., Principal investigator, Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497049
- Sponsor's protocol ID
- GP40221-P4-01-01
- Status last verified
- May 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221, Solution for Subcutaneous Administration 1.34 mg/ml (GEROPHARM) and Ozempic®, Solution for Subcutaneous Administration 1.34 mg/ml in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06497049
- Acronym / sponsor ID
- GP40221-P4-01-01
- Conditions
- Pharmacokinetics, Safety Issues, Bioequivalence
- Keywords
- semaglutide, ozempic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 11 Jul 2024 (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.
Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open randomized study of comparative pharmacokinetics and biosimilarity of GP40221, solution for subcutaneous administration, 1.34 mg/ml and Ozempic®, solution for subcutaneous administration, 1.34 mg/ml in parallel groups in healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| GP40221 | Experimental | Drug: GP40221GP40221 is administered subcutaneously into the subcutaneous fat of the anterior abdominal wall at a dose of 0.5 mg using a pen injector. |
| ozempic | Active comparator | Drug: ozempicOzempic® is administered subcutaneously into the subcutaneous fat of the anterior abdominal wall at a dose of 0.5 mg using a pen injector |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent to participate in the study.
- Males with a verified diagnosis "healthy" according to the data of standard clinical, laboratory and instrumental examination methods.
- Age 18-45 years old inclusive.
- Body mass index 18.5 - 29.9 kg/m2.
- Agree to use an adequate method of contraception (double barrier method) during the entire period of participation in the study and for 3 weeks after its completion.
Key exclusion criteria (28 listed)
- Burdened allergic history, drug intolerance.
- Hypersensitivity to heparin, semaglutide and any of the excipients of the study drug.
- Any acute and chronic diseases, incl. but not limited to:
- Deviations from normal values of heart rate (60-80), SBP (100-130 mm Hg), DBP (60-85 mm Hg), NPV (16-20), body temperature (35.7 - 37.0 °C).
- ECG Deviations, according to a specialist, during screening.
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 |
|---|---|---|
| GP40221Also: semaglutideSolution for Subcutaneous Administration 1.34 mg/ml | Drug | GP40221 |
| ozempicAlso: semaglutideSolution for Subcutaneous Administration 1.34 mg/ml | Drug | ozempic |
Primary outcome
AUC 0-t
Time frame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to the collection of the last blood sample with a determined concentration of the active substance at time point t
Cmax
Time frame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Maximum concentration of the active substance in the blood plasma of volunteers during the observation period
4 secondary outcomes
tmax
Time frame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
t1/2
Time frame: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
λz
Time frame: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
AUC0-∞
Time frame: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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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.
Sergei Noskov, MD, Pr. principal investigator
Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3"
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 GP40221 and ozempic in people with Pharmacokinetics and Safety Issues, 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 7 inclusion and 28 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 11 Jul 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.
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?
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?
AUC 0-t (time frame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after 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?
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 11 Jul 2024.