Clinical trial NCT06497049: Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Safety Issues
Bioequivalence
Keywords: semaglutide
ozempic
Lead sponsor: Geropharm
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

  1. diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract (including diseases of the colon), liver, kidneys, blood;
  2. 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).
* 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.

Primary outcomes:
measure: AUC 0-t
timeFrame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
measure: Cmax
timeFrame: -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:
measure: tmax
timeFrame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
measure: t1/2
timeFrame: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
measure: λz
timeFrame: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
measure: AUC0-∞
timeFrame: -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Other outcomes:
Locations:
city: Yaroslavl
country: Russian Federation
facility: Yarosslavl Clinical Hospital #3
Study officials:
affiliation: Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3"
name: Sergei Noskov, MD, Pr.
role: PRINCIPAL_INVESTIGATOR
References: