Pharmacokinetic Bioequivalence Study in Human Healthy VolunteersPhase 1NCT04014062

Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.

A Phase 1 study testing INTP5 and US Neulasta in people with Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers, run by Intas Pharmaceuticals, Ltd. at 1 site in India.

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

The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; INTP5 and US-Neulasta) in healthy, adult, human subjects under fed conditions. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
What is being tested?: INTP5 and US Neulasta
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteIndia
Study dates: 12 Feb 2018to 1 May 2018
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Normal, healthy adult human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
Having body weight ≥50 kg and body mass index (BMI) between 18.5 and 29.9 (both inclusive), calculated as weight in kg/height in meter^2.
Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (posterior-anterior view; within the last 6 months) recordings.
Volunteer who is a Non-smoker
Able to understand and comply with the study procedures, in the opinion of the investigator.
Able to give voluntary written informed consent for participation in the trial.

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In case of female subjects:
Surgically sterilized at least 6 months prior to study participation;- Or - If a woman of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
Serum pregnancy test (for female subjects) must be negative.

Who cannot join

Known hypersensitivity to the study drug or its constituents and/or hypersensitivity to E. coli derived proteins, and/or previous exposure to the study drug.
History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Known case of hereditary fructose intolerance.
Subjects with latex allergies will be excluded as the needle cover on the single-use pre-filled syringe contains dry natural rubber (latex).
Any clinically significant laboratory finding including ANC, platelet, RBC count or hemoglobin level at the time of screening.
Prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or Pegfilgrastim; Prior exposure to vaccines, immunoglobulin preparations, or immunomodulator's within the past 6 months prior to receiving the first dose; evidence of E. coli diarrhea or diseases within 3 months.

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Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria.
Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months.
History of any hematologic disease including sickle cell disorders.
Smokers, or who have smoked within last six months prior to start of the study.
Ingestion or use of any prescribed medication at any time within 1 month prior to receiving first dose in Period-I.
Receipt of over-the-counter medicines which have not yet cleared from the body (5 half-lives must have passed for the medicine to be considered to have cleared from the body).
A recent history of harmful use of alcohol, i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving study medicine in Period-I.
Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
Donation of blood (1 unit or 350 mL) or equivalent amount of blood substitute. Receipt of an investigational medicinal product or participation in a drug research study within a period of 180 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
Positive result for human immunodeficiency virus (HIV I \&/or II) and/or hepatitis B and C tests.
History or presence of cancer because of which anticipated life span is less than 5 years as per the investigator's assessment.
History or presence of psychiatric disorders.
Presence of tattoo or scars or any type of skin lesions due to infection, burning, wound or inflammation at the proposed site of injection.
An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to receiving the study medicine in Period-I. In any such case, subject selection will be at the discretion of the Principal Investigator.
Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug in Period-I.
A history of difficulty in donating blood.
Females, pregnant or lactating, or planning to become pregnant during the course of the study or found positive in pregnancy test at screening.
Any infections in the last 4 weeks before receiving study medication in Period-I.

Trial locations and contacts

1 site in 1 country.

India1 site

Lambda Therapeutic Research Ltd.
Ahmedabad, Gota, Ahmedabad-382481

Other trials in India

About this study

Official title: An Assessor-blind, Balanced, Randomized, Two-treatment, Two-period, Single-dose, Two-way, Crossover, Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects Under Fed Condition.

Conditions: Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Being tested: INTP5, US Neulasta
Keywords: Pegfilgrastim, Biosimilar, Bioequivalence, Pharmacokinetics, Pharmacodynamics, Safety, Healthy Volunteers

What participants receive

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

INTP5Combination product
INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.
US NeulastaCombination product
US Neulasta: FDA-approved pegfilgrastim innovator product.

Study groups in NCT04014062
Study group	Role	What they receive
INTP5 Period I Crossover	Experimental	Period I: Subjects received a single dose of INTP5 subcutaneously at a dose of 6 mg/0.6 mL. Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of US Neulasta. Receives: Combination Product: INTP5; Combination Product: US Neulasta
US Neulasta Period I Crossover	Active comparator	Period I: Subjects received a single dose US Neulasta subcutaneously at a dose of 6 mg/0.6 mL. Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of INTP5. Receives: Combination Product: INTP5; Combination Product: US Neulasta

What is being measured

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

Pharmacokinetic (PK) Endpoints: Pegfilgrastim C[Max]
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual subjects.
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
Pharmacokinetic (PK) Endpoints: Pegfilgrastim AUC[0-infinity]
Area under the serum concentration versus time curve from time zero to infinity. Where AUC[0-infinity]= AUC[0-t] + Ct/λz(lambda-z), Ct is the last measurable concentration and λz(lambda-z) is the terminal rate constant.
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
Pharmacodynamic (PD) Endpoints: E[Max] for Baseline Non-adjusted ANC
Maximum measured absolute neutrophil count (ANC).
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
Pharmacodynamic (PD) Endpoints: AUEC[0-t] for Baseline Non-adjusted ANC
Area under the absolute neutrophil count (ANC) versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.

Secondary outcomes (12)

PK Endpoint: Pegfilgrastim AUC[0-t]
Area under the serum concentration vs. time curve, calculated by linear trapezoidal rule from measured data points from the time zero to the time of last quantified concentration.
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim T[Max]
The time of observing the peak concentration, calculated from the serum concentration vs. time profile of the individual subjects.
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim λz(Lambda-z)
Terminal rate constant: First order rate constant associated with the terminal (log-linear) portion of the curve. This was estimated via linear regression of time vs. log concentration. This parameter was calculated by linear least squares regression analysis using last three or more nonzero plasma concentration values.
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim R^2 Adjusted
Goodness of fit statistic for the terminal phase, adjusted for the number of points used in the estimation of λz.
R^2 is the coefficient of Determination and can range from 0 to 1,; with higher values indicating greater predictability.
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim t[1/2]
The terminal half-life calculated using the formula 0.693/λz(lambda-z).
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim AUC[_Percent_Extrap_Obs]
The residual area in percentage determined by the formula, [(AUC[0-infinity]-AUC]0-t])/AUC0-infinity] x 100.
Measured: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PD Endpoint: T[Max] for Baseline Non-adjusted ANC
Time to reach the maximum measured absolute neutrophil count (ANC)
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: E[Max], Baseline-adjusted ANC
Maximum measured absolute neutrophil count (ANC)
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: AUEC[0-t], Baseline-adjusted ANC
Area under the absolute neutrophil count (ANC) versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: T[Max], Baseline-adjusted ANC
Time to reach the maximum measured absolute neutrophil count (ANC)
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: λz(Lamda-z) and Baseline-adjusted ANC
First order rate constant associated with the terminal (log-linear) portion of the curve. This is estimated via linear regression of time vs. log concentration.
This parameter will be calculated by linear least squares regression analysis using at least last three or more non-zero values.
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: t[1/2] for Baseline-adjusted ANC
The terminal half-life will be calculated as 0.693/λz(lamda-z).
Measured: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.

Timeline

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

12 Feb 20181 May 2018

First posted10 Jul 2019
Study start12 Feb 2018
Primary completion1 May 2018
Study completion1 May 2018

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 Pharmacokinetic Bioequivalence Study in Human Healthy VolunteersStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04014062
Sponsor's protocol ID: 0553-17
Status last verified: Sep 2019
First submitted: 8 Jul 2019
Last updated: 4 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Assessor-blind, Balanced, Randomized, Two-treatment, Two-period, Single-dose, Two-way, Crossover, Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects Under Fed Condition.
ClinicalTrials.gov ID: NCT04014062
Acronym / sponsor ID: 0553-17
Conditions: Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Keywords: Pegfilgrastim, Biosimilar, Bioequivalence, Pharmacokinetics, Pharmacodynamics, Safety, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Intas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
Collaborators: Lambda Therapeutic Research Ltd.
Study start: 12 Feb 2018 (actual)
Primary completion: 1 May 2018 (actual)
Study completion: 1 May 2018 (actual)
First posted: 10 Jul 2019 (actual)
Results: Posted 4 Oct 2019

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
INTP5 Period I Crossover	Experimental	Combination Product: INTP5, Combination Product: US NeulastaPeriod I: Subjects received a single dose of INTP5 subcutaneously at a dose of 6 mg/0.6 mL. Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of US Neulasta.
US Neulasta Period I Crossover	Active comparator	Combination Product: INTP5, Combination Product: US NeulastaPeriod I: Subjects received a single dose US Neulasta subcutaneously at a dose of 6 mg/0.6 mL. Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of INTP5.

Who may qualify

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

Key inclusion criteria (9 listed)

Normal, healthy adult human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
Having body weight ≥50 kg and body mass index (BMI) between 18.5 and 29.9 (both inclusive), calculated as weight in kg/height in meter^2.
Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (posterior-anterior view; within the last 6 months) recordings.
Volunteer who is a Non-smoker
Able to understand and comply with the study procedures, in the opinion of the investigator.

Key exclusion criteria (24 listed)

Known hypersensitivity to the study drug or its constituents and/or hypersensitivity to E. coli derived proteins, and/or previous exposure to the study drug.
History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Known case of hereditary fructose intolerance.
Subjects with latex allergies will be excluded as the needle cover on the single-use pre-filled syringe contains dry natural rubber (latex).
Any clinically significant laboratory finding including ANC, platelet, RBC count or hemoglobin level at the time of screening.

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
INTP5INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.	Combination product	INTP5 Period I Crossover, US Neulasta Period I Crossover
US NeulastaUS Neulasta: FDA-approved pegfilgrastim innovator product.	Combination product	INTP5 Period I Crossover, US Neulasta Period I Crossover

Primary outcome

Pharmacokinetic (PK) Endpoints: Pegfilgrastim C[Max]
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual subjects.
Pharmacokinetic (PK) Endpoints: Pegfilgrastim AUC[0-infinity]
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
Area under the serum concentration versus time curve from time zero to infinity. Where AUC[0-infinity]= AUC[0-t] + Ct/λz(lambda-z), Ct is the last measurable concentration and λz(lambda-z) is the terminal rate constant.
Pharmacodynamic (PD) Endpoints: E[Max] for Baseline Non-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
Maximum measured absolute neutrophil count (ANC).
Pharmacodynamic (PD) Endpoints: AUEC[0-t] for Baseline Non-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
Area under the absolute neutrophil count (ANC) versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.

12 secondary outcomes

PK Endpoint: Pegfilgrastim AUC[0-t]
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim T[Max]
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim λz(Lambda-z)
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim R^2 Adjusted
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim t[1/2]
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PK Endpoint: Pegfilgrastim AUC[_Percent_Extrap_Obs]
Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.
PD Endpoint: T[Max] for Baseline Non-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: E[Max], Baseline-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: AUEC[0-t], Baseline-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: T[Max], Baseline-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: λz(Lamda-z) and Baseline-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.
PD Endpoint: t[1/2] for Baseline-adjusted ANC
Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.

Results and safety

Results posted to the registry on 4 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INTP5 Period I, US Neulasta Period II Crossover	71	64
US Neulasta Period I, INTP5 Period II Crossover	71	65

Primary outcome: Pharmacokinetic (PK) Endpoints: Pegfilgrastim C[Max]

Time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.. Mean (Standard Deviation). Unit: ng/mL

Measure	INTP5 Treatment n = 129	US Neulasta Treatment n = 129
Value	474.269 (240.2247)	425.578 (219.8054)

Primary outcome: Pharmacokinetic (PK) Endpoints: Pegfilgrastim AUC[0-infinity]

Measure	INTP5 Treatment n = 128	US Neulasta Treatment n = 127
Value	21015.8632 (12985.3760)	18327.4192 (11156.1580)

Population analysed: 3 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PK parameters

Primary outcome: Pharmacodynamic (PD) Endpoints: E[Max] for Baseline Non-adjusted ANC

Time frame: Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.. Mean (Standard Deviation). Unit: x10^3 cells/uL

Measure	INTP5 Treatment n = 129	US Neulasta Treatment n = 129
Value	38.82 (9.009)	37.97 (9.258)

Primary outcome: Pharmacodynamic (PD) Endpoints: AUEC[0-t] for Baseline Non-adjusted ANC

Measure	INTP5 Treatment n = 128	US Neulasta Treatment n = 125
Value	6638.12 (1404.376)	6554.04 (1465.072)

Population analysed: 5 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PD parameters.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 79 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INTP5 Treatment	0 of 136 (0%)	39 of 136 (28.7%)	0 of 136
US Neulasta Treatment	0 of 135 (0%)	39 of 135 (28.9%)	0 of 135

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Anshul Attrey, M.D. principal investigator

Lambda Therapeutic Research Ltd.

Vinu Jose, M.D. study director

Intas Pharmaceuticals, Ltd.

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 INTP5 and US Neulasta in people with Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers, run by Intas Pharmaceuticals, Ltd. at 1 site in India.

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 9 inclusion and 24 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 4 Oct 2019. 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 India. 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 4 Oct 2019). 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?

Pharmacokinetic (PK) Endpoints: Pegfilgrastim C[Max] (time frame: Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.). 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 NCT04014062.

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 4 Oct 2019.