Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers

NCT02506881 | Completed Phase 1 Results

• 1 other identifier: BCD-066-1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval of at least 25 days.

Conditions

Healthy

Keywords

darbepoetin alfa; pharmacokinetics; pharmacodynamics; healthy volunteers

Outcome Measures

Primary Outcomes (4)

• AUC

  Area Under Concentration-time Curve (AUC) of Darbepoetin Alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) Hours and to Infinity(AUC(0-336)/AUC(0-72) and AUC(0-∞) Respectively Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.

  336 hours (sc) / 72 hours (iv)

• Cmax

  Maximal concentration of darbepoetin alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) hours. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.

  336 hours (sc) / 72 hours (iv)

• AUEC

  Area Under Effect Curve (AUEC) of reticulocytes count from the Moment of Drug Administration Until 504 hours. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.

  504 hours

• AC-Emax

  Maximum elevation of absolute reticulocyte count from the baseline from the Moment of Drug Administration Until 504 hours. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.

  504 hours

Secondary Outcomes (3)

• T1/2

  336 hours (sc) / 72 hours (iv)

• Tmax

  336 hours (sc) / 72 hours (iv)

• Cl

  336 hours (sc) / 72 hours (iv)

Study Arms (4)

BCD-066 → Aranesp - subcutaneous

EXPERIMENTAL

Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.

Drug: Darbepoetin alfa

Aranesp → BCD-066 - subcutaneous

EXPERIMENTAL

Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.

Drug: Darbepoetin alfa

BCD-066 → Aranesp - intravenous

EXPERIMENTAL

Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.

Drug: Darbepoetin alfa

Aranesp → BCD-066 - intravenous

EXPERIMENTAL

Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfa DRUG

Also known as: Aranesp, BCD-066

Aranesp → BCD-066 - intravenous; Aranesp → BCD-066 - subcutaneous; BCD-066 → Aranesp - intravenous; BCD-066 → Aranesp - subcutaneous

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent
• Male gender
• Age 18 - 45 years inclusively
• Body mass index (BMI) 19 - 29 kg/m2 inclusively
• Hemoglobin level 120-160 g/l (12 - 16 g/dL) inclusively during 14 days prior to first study drugs administration
• White blood cells count ≥3,0×109/L, Platelet count ≥140×109/L during 14 days prior to first study drugs administration
• Subjects must be in good health as determined by a medical history, medical examination, electrocardiogram, serum biochemistry, haematology, serology and urinalysis
• Absence of history of systematic alcohol and drug abuse
• Ability of the volunteer, in investigator's opinion, to follow the study protocol procedures and requirements
• Consent to avoid alcohol intake within 24 hours before and 48 hours after each administration of the test or reference drugs

You may not qualify if:

• Clinically significant abnormalities on ECG or in laboratory tests, which could interfere with the objective of the study or the safety of the volunteer.
• Clinically significant illness within 4 weeks prior to the screening visit
• Subjects with past or present history of liver disease, angina, renal disease, hypertension, epilepsy, cardiovascular, cerebrovascular, peripheral vascular disease or thrombocytosis
• History of any oncological disease
• Prior exposure to any erythropoietins, darbepoetin
• Prior exposure to IV iron supplementation (within 2 years before randomisation)
• Subjects who have used any medication, including over-the-counter drugs, herbal medications, and nutritional supplements within 14 days prior to IDs administration with the exception of paracetamol (acetaminophen) up to 3g per day or ibuprofen up to 1g per day
• Subjects who smoke more than 10 cigarettes per day
• Subjects who have donated more than 450 ml of blood within the 1 month prior to ID injection
• Epileptic seizures within the 6 months prior to ID injection
• Major surgery within 1 month prior to the enrollment into the study
• Inability to install intravenous catheter (e.g., due to skin disease)
• Subjects who have received any experimental drug within 3 months preceding the 1st ID administration
• Subjects who have a clinically significant history of drug hypersensitivity or allergic disease
• Possibility that the subject will not cooperate with the requirements of the protocol as set out in the volunteer information

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

City Mariin Hospital

Saint Petersburg, 194104, Russia

Location

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Biryulin Andrey
• Organization: BIOCAD

biryulin@biocad.ru

+7812380 49 33

Study Officials

• Ivan Sardaryan, PhD

  City Mariin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 14, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-05

Locations

RU (1)