Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

NCT05652595 | Unknown Phase 1 DMC

• 1 other identifier: GP40141-P4-31
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacodynamics; Pharmacokinetics; Bioequivalence

Keywords

romiplostim

Outcome Measures

Primary Outcomes (2)

• 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)

  -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)

  -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

  -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

  -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

  -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

  -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

  -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

Study Arms (2)

TR Sequence

EXPERIMENTAL

first Intervention period - subjects are administered test medecine (GP40141) and in seconde Intervention period subjects are administered reference medecine (Nplate)

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)

Drug: GP40141; Drug: Nplate

Interventions

GP40141 DRUG

Once, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area

Also known as: romiplostim

RT Sequence; TR Sequence

Nplate DRUG

Once, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area

Also known as: romilostim

RT Sequence; TR Sequence

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

Yaroslavl Region "Clinical Hospital No. 3", ,, Mayakovskogo st., 61

Yaroslavl, 150007, Russia

RECRUITING

Related Publications (1)

• 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.

  PMID: 37740581 DERIVED

MeSH Terms

Interventions

romiplostim

Study Officials

• Igor Mr Makarenko, PhD

  GEROPHAM

  STUDY CHAIR

Central Study Contacts

Igor Mr Makarenko, PhD

CONTACT

+78124935501; Igor.Makarenko@geropharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, cross-over study of comparative pharmacodynamics and pharmacokinetics

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: June 3, 2022
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)