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Healthy VolunteersPhase 1NCT02479646

Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta

A Phase 1 study testing MYL-1401H, EU-Neulasta and US-Neulasta in people with Healthy Volunteers, run by Mylan Inc. at 1 site in Netherlands.

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

This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
MYL-1401H, EU-Neulasta and US-Neulasta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteNetherlands
Study dates
Sep 2014to Jun 2015
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Weight: ≥60 kg.
  • Body mass index (BMI): 19.0-30.0 kg/m2
  • Vital signs showing no clinically relevant deviations.
  • Computerized 12-lead ECG recording without signs of clinically relevant pathology.
  • Non-smoker or light smoker
  • Ability and willingness to abstain from alcohol from 48 hours prior to each admission to the clinical research center and prior to ambulatory visits, and during the stays in the clinic.
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  • Fertile males and females participating in heterosexual sexual relations: willingness to use adequate contraception from screening until 90 days after the follow up visit
  • Females must not be lactating and must have a negative pregnancy test at screening and each admission.
  • ANC, total leukocyte count, platelet count, hematocrit and hemoglobin results within the reference ranges.
  • All other values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Principal Investigator
  • Other protocol specific inclusion/exclusion criteria may apply

Who cannot join

  • Unable to follow protocol instructions in the opinion of the Principal Investigator.
  • Any past or concurrent medical conditions that potentially increase the subject's risks or affect the evaluation of any study results. Examples of these include medical history with evidence of clinically relevant pathology (e.g. sickle cell disorders, spleen pathologies, hematologic malignancies or myelodysplastic disorders, and pulmonary illnesses such as ARDS, interstitial pneumonia, pulmonary edema, pulmonary infiltrates and pulmonary fibrosis) and history of relevant drug and/or food allergies.
  • Known history of previous exposure to filgrastim, pegfilgrastim, granulocyte colony stimulating factor (GCSF) or any analogue of these.
  • Hypersensitivity to the constituents of Neulasta® (sorbitol E420, polysorbate 20 and acetate or acetic acid) or hypersensitivity to E. coli derived proteins.
  • Any infection, cough or fever within 1 week prior to first study drug administration.
  • Fructose intolerance.
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  • First degree relatives with hematological malignancy.
  • Treatment with non-topical medications within 5 days prior to first admission to the clinical research center, with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a limited amount of paracetamol (acetaminophen), which may be used throughout the study.
  • Participation in a drug study within 60 days prior to study drug administration.
  • Donation or loss of more than 500 mL of blood over a period of 60 days prior to study drug administration. Donation of more than 1.5 L of blood (for men) / more than 1.0 L of blood (for women) in the 10 months preceding the start of this study.
  • History of alcohol abuse or drug addiction
  • Regular intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits).
  • Positive drug screen (opiates, methadone, cocaine, amphetamines (including ecstasy), cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol).
  • Positive screen on hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1/2 antibodies.
  • Other protocol specific inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Health Sciences - Early Development Services

    Zuidlaren, 9471

Other trials in Netherlands

About this study

Official title: Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta®) in Healthy Volunteers.

This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.

Read the detailed description

After successful screening, each subjects will be randomly allocated to one of the following six possible sequences, according a 1:1:1:1:1:1 randomization scheme:

Sequence_1: Treatment A -> Treatment B -> Treatment C ; Sequence_2: Treatment A -> Treatment C -> Treatment B ; Sequence_3: Treatment B -> Treatment A -> Treatment C ; Sequence_4: Treatment B -> Treatment C -> Treatment A ; Sequence_5: Treatment C -> Treatment A -> Treatment B ; Sequence_6: Treatment C -> Treatment B -> Treatment A ;

In study Period 1, Subjects will be administered MYL-1401H (Treatment A), EU-Neulasta(Treatment B) or US-Neulasta (Treatment C).

After the 1st crossover, subjects will enter Study period 2 and will receive one of the remaining alternate treatments.

After the 2nd crossover, subjects will enter Study period 3 and will receive the other alternate treatment.

The washout between drug administrations is at least 4 weeks. Final follow-up visit is scheduled 4 weeks after the last study drug administration.

Being tested
MYL-1401H, EU-Neulasta, US-Neulasta
Keywords
Pegfilgrastim, G-CSF, Pharmacokinetics, Pharmacodynamics

What participants receive

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

  • MYL-1401HBiological

    Also called Recombinant human granulocyte colony-stimulating factor (G-CSF), Pegfilgrastim

  • EU-NeulastaBiological

    Also called Recombinant human granulocyte colony-stimulating factor (G-CSF), Pegfilgrastim

  • US-NeulastaBiological

    Also called Recombinant human granulocyte colony-stimulating factor (G-CSF), Pegfilgrastim

Study groups in NCT02479646
Study groupRoleWhat they receive
Treatment AExperimentalMYL-1401H: single subcutaneous injection (2mg)
Receives: Biological: MYL-1401H
Treatment BActive comparatorEU-Neulasta: single subcutaneous injection (2mg)
Receives: Biological: EU-Neulasta
Treatment CActive comparatorUS-Neulasta: single subcutaneous injection (2mg)
Receives: Biological: US-Neulasta

What is being measured

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

  1. Pharmacodynamics: Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]

    Measured: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), and on Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29

  2. Pharmacodynamics: Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax

    Measured: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29

  3. Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim

    Pharmacokinetics as measured by total AUC after extrapolation from time t to time infinity

    Measured: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29

  4. Maximum Serum Concentration (Cmax) of pegfilgrastim

    Pharmacokinetics as measured by peak serum concentration of Pegfilgrastim

    Measured: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29

Secondary outcomes (3)

  1. Frequency of Adverse Events

    Safety as measured by incidence of Adverse Events

    Measured: Daily until Day 9, then on Day 12, 15, 22 of each study period, and at follow-up visit (day 84).

  2. Safety Variable - Tolerability as measured by Injection Site reactions

    Tolerability as measured by Injection Site reactions

    Measured: Daily until Day 5 of each period

  3. Safety Variable - Immunogenicity as measured by presence of Anti Drug Antibodies

    Immunogenicity as measured by presence of Anti Drug Antibodies

    Measured: Day 1 each period and at follow-up (Day 84)

Timeline

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

  1. First posted24 Jun 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02479646
Sponsor's protocol ID
MYL-1401H-1001
Other IDs
2014-002229-37, 2014
Status last verified
Feb 2022
First submitted
3 Jun 2015
Last updated
14 Feb 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MYL-1401H, EU-Neulasta and US-Neulasta in people with Healthy Volunteers, run by Mylan Inc. at 1 site in Netherlands.

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 15 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 Feb 2022. 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 Netherlands. 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?

Pharmacodynamics: Area under the curve above baseline of ANC [ANC_AUC(0-tlast)] (time frame: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), and on Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29). 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 NCT02479646.

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 Feb 2022.

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