AzTrials
AzTrials

PharmacokineticsPhase 1NCT02306915

PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants

A Phase 1 study testing lipegfilgrastim in people with Pharmacokinetics and Pharmacodynamics, run by Merckle GmbH at 1 site in United Kingdom.

Completed

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

Official record
Search all trials

Trial summary

Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching. Every effort will be made to match Caucasian and Japanese participants on a cohort basis at enrollment. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics, Pharmacodynamics
What is being tested?
lipegfilgrastim
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2014to May 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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index (BMI) ≥18.0 and ≤25 kg/m2.
  • Body weight must be ≥ 50 kg and ≤ 90 kg.
  • Is in good general health as determined by medical history, physical examination, 12-lead electrocardiography (ECG), vital signs and clinical laboratory tests.
  • Subjects are able to read, write and understand English or Japanese; they must be able to understand the requirements of the study and be willing to comply with all trial requirements.
  • Female subjects of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) test at screening and negative urine pregnancy test at check-in. All subjects must be either surgically sterile (for females that means documented complete hysterectomy, bilateral oophorectomyor bi-tubal ligations; partial hysterectomy is not sufficient), abstinent throughout the study or, if of reproductive capacity and not abstinent, exercising any 2 different forms of highly effective contraception methods with his/her partner during the entire study period.
  • o Additional inclusion criteria for Japanese subjects:
Show all 12Show fewer
  • Subject must be a non-naturalized Japanese citizen and hold a Japanese passport.
  • Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non-naturalized Japanese citizens, as confirmed by interview.
  • Subject has been living outside of Japan for 10 years or fewer as confirmed by interview.
  • o Additional inclusion criterion for Caucasian subjects:
  • The subject is Caucasian, and confirms by interview that his/her parents and grandparents are Caucasian and none are of Black/African descent, Middle-Eastern descent or Asian descent.
  • -other criteria apply, please contact the investigator for more information

Who cannot join

  • History of hypersensitivity to pegfilgrastim, filgrastim, lenograstim, Escherichia coli derived proteins, or to any excipients (glacial acetic acid, sodium hydroxide, sorbitol, polysorbate 20).
  • Prior exposure to filgrastim, pegfilgrastim or lenograstim or other granulocyte colony stimulating factors (G-CSFs) in clinical development less than 6 months before randomization.
  • Findings of splenomegaly on sonography, defined by splenic length in excess of 12.3 cm (Andrews, 2000; Benter et al, 2011) and clinical judgment.
  • Existence or recent history of persistent pulmonary infiltrates or recent pneumonia, or current symptoms of upper respiratory infection. In the case of pneumonia, subject may be screened 12 weeks following cessation of antibiotic treatment.
  • -other criteria apply, please contact the investigator for more information

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Teva Investigational Site 34193

    London

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Subcutaneous Administration of Lipegfilgrastim (Doses up to 100 μg/kg) in Healthy Japanese and Caucasian Subjects

Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching. Every effort will be made to match Caucasian and Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to maintain balance between male and female participants within the cohorts. There will be no replacement of participants following randomization.

Read the detailed description

Eligible participants will be admitted to the investigational center and after confirming their eligibility will be randomized to receive a single dose of 30, 60, or 100 μg/kg lipegfilgrastim. There will be 11 visits to the investigational center during the study, including a screening visit, 1 inpatient period (through Day 4 post-dose) and 9 ambulatory visits.

Blood samples for PK, PD and immunogenicity analysis will be collected pre-dose and at specified time points post-dose. A mandatory blood sample for pharmacogenetics (PGx) will be collected from all participants. During the study the following safety assessments will be performed: vital signs measurements,physical examinations, record of adverse events, clinical laboratory tests, urinalysis, safety ECG recordings, local tolerability (injection site reactions), overall tolerability, pregnancy testing, spleen sonography, and concomitant medications

Being tested
lipegfilgrastim
Keywords
Lipegfilgrastim, Lonquex, Japanese Bridging

What participants receive

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

  • lipegfilgrastimDrug

    lipegfilgrastim 30 μg/kg, 60 μg/kg, 100 μg/kg

Study groups in NCT02306915
Study groupRoleWhat they receive
lipegfilgrastim 30ExperimentalNot described
Receives: Drug: lipegfilgrastim
lipegfilgrastim 60ExperimentalNot described
Receives: Drug: lipegfilgrastim
lipegfilgrastim 100ExperimentalNot described
Receives: Drug: lipegfilgrastim

What is being measured

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

  1. PK: Area under the serum concentration-time curve (AUC), from time 0 to the last measurable concentration (AUC0-t)

    2 hours for visits 3, 9; 1 day for visit 10

    Measured: Days 1-8, 10, 14, 17, 21

  2. AUC from time 0 extrapolated to infinity (AUC0-∞)

    Measured: Days 1-8, 10, 14, 17, 21

  3. Maximum observed serum drug concentration (Cmax)

    Measured: Days 1-8, 10, 14, 17, 21

  4. Time to maximum observed serum drug concentration (tmax)

    Measured: Days 1-8, 10, 14, 17, 21

  5. The percentage of the extrapolated area to infinity in relation to the total area under the curve (%AUCext)

    Measured: Visits 3, 9, 10

  6. Apparent serum terminal elimination rate constant (λz)

    2 hours for visits 3, 9; 1 day for visit 10

    Measured: Days 1-8, 10, 14, 17, 21

  7. Associated elimination half-life (t½)

    Measured: Days 1-8, 10, 14, 17, 21

  8. Mean residence time (MRT)

    Measured: Days 1-8, 10, 14, 17, 21

  9. Apparent total body clearance (CL/F)

    Measured: Days 1-8, 10, 14, 17, 21

  10. Apparent volume of distribution during the terminal phase (Vz/F)

    Measured: Days 1-8, 10, 14, 17, 21

  11. PD: ANC area over baseline effect curve (ANC AOBEC)

    Measured: Days 1-8, 10, 14, 17, 21

  12. Maximum measured ANC value after dosing (ANC Cmax)

    Measured: Days 1-8, 10, 14, 17, 21

  13. Time point at which ANC Cmax is observed (ANC tmax)

    Measured: Days 1-8, 10, 14, 17, 21

  14. Time (days) until ANC returns to baseline value

    Measured: Days 1-8, 10, 14, 17, 21

  15. CD34+ area over the baseline effect curve (CD34+ AOBEC)

    Measured: Days 1-8, 10, 14, 17, 21

  16. Maximum measured CD34+ value after dosing (CD34+ Cmax)

    Measured: Days 1-8, 10, 14, 17, 21

  17. Time point at which CD34+ Cmax is observed (CD34+ tmax)

    Measured: Days 1-8, 10, 14, 17, 21

Secondary outcomes (1)

  1. Percentage of Participants with Adverse Events

    Measured: 28 Days

Timeline

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

  1. First posted3 Dec 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionMar 2015
  4. Study completionMay 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02306915
Sponsor's protocol ID
XM22-PK-10036
Status last verified
Nov 2021
First submitted
1 Dec 2014
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lipegfilgrastim in people with Pharmacokinetics and Pharmacodynamics, run by Merckle GmbH at 1 site in United Kingdom.

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 12 inclusion and 5 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 9 Nov 2021. 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 United Kingdom. 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?

PK: Area under the serum concentration-time curve (AUC), from time 0 to the last measurable concentration (AUC0-t) (time frame: Days 1-8, 10, 14, 17, 21). The study lists 17 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 NCT02306915.

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 9 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in