HealthyPhase 1NCT02506881

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

A Phase 1 study testing Darbepoetin alfa in people with Healthy, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Darbepoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteRussia
Study dates: Mar 2013to Jul 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 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

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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
Willingness of volunteers and their sexual partners of childbearing potential to use reliable contraception methods starting from 2 weeks before inclusion into the study and until 4 weeks after receiving the last dose of the investigational products. This criterion is not applicable to patients who underwent surgical sterilization. Reliable contraceptive measures include one barrier method in combination with one of the following methods: spermicides, intrauterine device or oral contraceptives used by participant's partner
Consent to avoid alcohol intake within 24 hours before and 48 hours after each administration of the test or reference drugs

Who cannot join

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)

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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
Subjects who consume excessive amounts of caffeine (more than 5 cups of coffee per day)
Participation in any other clinical study or any preceding participation in other studies within 3 months prior to the 1st ID administration

Trial locations and contacts

1 site in 1 country.

Russia1 site

City Mariin Hospital
Saint Petersburg, 194104

Other trials in Russia

About this study

Official title: International Multicenter Comparative Randomized Double-blind Crossover Study of Pharmacokinetics, Pharmacodynamics and Safety of BCD-066 and Aranesp® After Single Subcutaneous and Intravenous Injection in Healthy Volunteers.

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
Being tested: Darbepoetin alfa
Keywords: darbepoetin alfa, pharmacokinetics, pharmacodynamics, healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Darbepoetin alfaDrug
Also called Aranesp, BCD-066

Study groups in NCT02506881
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 504 hours

Secondary outcomes (3)

T1/2
Serum half-life of darbepoetin alfa after single sc of iv administration. 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.
Measured: 336 hours (sc) / 72 hours (iv)
Tmax
Time to achieve maximum serum concentration of darbepoetin alfa after single sc of iv administration
Measured: 336 hours (sc) / 72 hours (iv)
Cl
Serum clearance of of darbepoetin alfa after single sc of iv administration. 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.
Measured: 336 hours (sc) / 72 hours (iv)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jul 2014

First posted23 Jul 2015 (estimated)
Study startMar 2013
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by BiocadThe sponsor's other registered studies.
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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02506881
Sponsor's protocol ID: BCD-066-1
Status last verified: May 2016
First submitted: 22 Jul 2015
Last updated: 14 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Multicenter Comparative Randomized Double-blind Crossover Study of Pharmacokinetics, Pharmacodynamics and Safety of BCD-066 and Aranesp® After Single Subcutaneous and Intravenous Injection in Healthy Volunteers.
ClinicalTrials.gov ID: NCT02506881
Acronym / sponsor ID: BCD-066-1
Conditions: Healthy
Keywords: darbepoetin alfa, pharmacokinetics, pharmacodynamics, healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 23 Jul 2015 (estimated)
Results: Posted 2 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BCD-066 → Aranesp - subcutaneous	Experimental	Drug: Darbepoetin alfaVolunteers 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.
Aranesp → BCD-066 - subcutaneous	Experimental	Drug: Darbepoetin alfaVolunteers 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.
BCD-066 → Aranesp - intravenous	Experimental	Drug: Darbepoetin alfaVolunteers 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.
Aranesp → BCD-066 - intravenous	Experimental	Drug: Darbepoetin alfaVolunteers 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.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (17 listed)

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

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
Darbepoetin alfaAlso: Aranesp, BCD-066	Drug	Aranesp → BCD-066 - intravenous, Aranesp → BCD-066 - subcutaneous, BCD-066 → Aranesp - intravenous, BCD-066 → Aranesp - subcutaneous

Primary outcome

AUC
Time frame: 336 hours (sc) / 72 hours (iv)
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.
Cmax
Time frame: 336 hours (sc) / 72 hours (iv)
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.
AUEC
Time frame: 504 hours
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.
AC-Emax
Time frame: 504 hours
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.

3 secondary outcomes

T1/2
Time frame: 336 hours (sc) / 72 hours (iv)
Tmax
Time frame: 336 hours (sc) / 72 hours (iv)
Cl
Time frame: 336 hours (sc) / 72 hours (iv)

Results and safety

Results posted to the registry on 2 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BCD-066 → Aranesp - Subcutaneous	13	12
Aranesp → BCD-066 - Subcutaneous	12	12
BCD-066 → Aranesp - Intravenous	25	12
Aranesp → BCD-066 - Intravenous	24	12

Primary outcome: AUC

Time frame: 336 hours (sc) / 72 hours (iv). Median (Inter-Quartile Range). Unit: (pg/ml)*hour

Measure	BCD-066 Subcutaneous n = 24	Aranesp® Subcutaneous n = 24	BCD-066 - Intravenous n = 23	Aranesp® - Intravenous n = 23
Value	150607 (115435 to 185031)	152208 (116362 to 212041)	504584 (463396 to 626538)	544818 (456106 to 606407)

Population analysed: Population for pharmacokinetics analysis: patients who received at least one study drug injection.

Primary outcome: Cmax

Time frame: 336 hours (sc) / 72 hours (iv). Median (Inter-Quartile Range). Unit: pg/ml

Measure	BCD-066 Subcutaneous n = 24	Aranesp® Subcutaneous n = 24	BCD-066 - Intravenous n = 23	Aranesp® - Intravenous n = 23
Value	984 (789 to 1226)	885 (808 to 1197)	23908 (21535 to 27531)	24478 (22271 to 29381)

Population analysed: Population for pharmacokinetics analysis included patients who received at least one study drug injection.

Primary outcome: AUEC

Time frame: 504 hours. Median (Inter-Quartile Range). Unit: (reticulocytes * 10^9/l)*hour

Measure	BCD-066 Subcutaneous n = 24	Aranesp® Subcutaneous n = 24	BCD-066 - Intravenous n = 23	Aranesp® - Intravenous n = 23
Value	28248 (22162 to 32648)	27916 (22827 to 32628)	35610 (29578 to 41423)	36928 (28773 to 42247)

Population analysed: Population for pharmacokinetics analysis included patients who received at least one study drug injection.

Primary outcome: AC-Emax

Time frame: 504 hours. Median (Inter-Quartile Range). Unit: reticulocytes * 10^9/l

Measure	BCD-066 Subcutaneous n = 24	Aranesp® Subcutaneous n = 24	BCD-066 - Intravenous n = 23	Aranesp® - Intravenous n = 23
Value	44.8 (26.8 to 62.3)	54.55 (40.7 to 69.0)	71.3 (51.9 to 85.3)	72.1 (55.5 to 86.7)

Population analysed: Population for analysis of pharmacodynamics included patients who received at least one study drug injection.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 0 to 504 hours after injection. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BCD-066 Subcutaneous	0 of 25 (0%)	23 of 25 (92%)	Not reported
Aranesp® Subcutaneous	0 of 25 (0%)	22 of 25 (88%)	Not reported
BCD-066 - Intravenous	0 of 49 (0%)	44 of 49 (89.8%)	Not reported
Aranesp® - Intravenous	0 of 49 (0%)	42 of 49 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ivan Sardaryan, PhD principal investigator

City Mariin Hospital

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 Darbepoetin alfa in people with Healthy, run by Biocad 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 11 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: finished, as of the sponsor's last update on 14 Jun 2016. 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?

Yes. Results are posted in the registry (first posted 2 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: 336 hours (sc) / 72 hours (iv)). The study lists 4 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 NCT02506881.

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 14 Jun 2016.