CTRI/2017/10/010040 [Registered on: 06/10/2017] Trial Registered Retrospectively
Last Modified On:
06/10/2017
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Crossover Trial
Public Title of Study
PK and PD study of G-CSF (BioGenomics Ltd) vs Neupogen® in healthy volunteers
Scientific Title of Study
A Phase I, Single-centre, Randomized, Double-Blind, Two Treatment, Two-Period, Two-sequence, Two-way Crossover Study to Demonstrate Equivalence of Pharmacokinetic and Pharmacodynamic Characteristics and to Compare Safety and Tolerability of Granulocyte Colony Stimulating Factor (BioGenomics Limited) and Neupogen® Administered via Subcutaneous Route as Multiple Consecutive Doses in Healthy Adult Human Volunteers
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BGL/GCSF/PROTOCOL/IN/01-15 Version 3 dated 31 July 2015
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Hiren Prajapati
Designation
Principal Investigator
Affiliation
Veeda Clinical Research
Address
Veeda Clinical Research Pvt. Ltd. Shivalik Plaza Wing-A, Near IIM, Ambawadi, Ahmedabad – 380 015, India
Ahmadabad GUJARAT 380 015 India
Phone
9179-30013000
Fax
9179-30013010
Email
hiren.prajapati@veeda.com
Details of Contact Person Scientific Query
Name
Dr Chandrashekhar Bolmall MD
Designation
Medical Director- Clinical Research
Affiliation
BioGenomics Limited
Address
BioGenomics Limited, First Floor, Kothari Compound, Opp. Tikuji ni wadi, Thane (W)-400610, Maharashtra, India BioGenomics Limited, First Floor, Kothari Compound, Opp. Tikuji ni wadi, Thane (W)-400610, Maharashtra, India Thane MAHARASHTRA 400610 India
Phone
022-41617181
Fax
022-41617199
Email
chandrashekhar.bolmall@biogenomics.co.in
Details of Contact Person Public Query
Name
Dr Chandrashekhar Bolmall MD
Designation
Medical Director-Clinical Research
Affiliation
BioGenomics Limited
Address
BioGenomics Limited, First Floor, Kothari Compound, Opp. Tikuji ni wadi, Thane (W)-400610, Maharashtra, India BioGenomics Limited, First Floor, Kothari Compound, Opp. Tikuji ni wadi, Thane (W)-400610, Maharashtra, India Thane MAHARASHTRA 400610 India
Phone
022-41617181
Fax
022-41617199
Email
chandrashekhar.bolmall@biogenomics.co.in
Source of Monetary or Material Support
BioGenomics Ltd. First Floor, Kothari Compound, Opp. Tikuji-ni-wadi Thane (W) -400601, Maharashtra, India
Primary Sponsor
Name
BioGenomics Ltd
Address
BioGenomics Ltd. First Floor, Kothari Compound, Opp. Tikuji-ni-wadi Thane (W) -400601, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Hiren Prajapati
Veeda Clinical Research
Shivalik Plaza,
Near I.I.M, Ambawadi,
Ahmedabad 380 015,
India Ahmadabad GUJARAT
G-CSF 300 mcg/0.5 mL Prefilled Syringe for Subcutaneous route
Dose - 0.5 mcg/kg/day once daily for 5 days
Comparator Agent
Neupogen®
Neupogen® 300 mcg/0.5 mL Prefilled Syringe for Subcutaneous route
Dose - 0.5 mcg/kg/day once daily for 5 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
Inclusion Criteria
1. Willingness to provide informed consent to participate in the study.
2. Body Mass Index (BMI) between 18.0 kg/m2 to 27.0 kg/m2 (both inclusive) with minimum weight of 50 kg.
3. Nonalcoholic, nonsmoker, healthy, adult, human male volunteers of any race within the age range of 18 to 45 years (both inclusive)living in and around Ahmedabad city or Western part of India.
4. No history of any major illness in the past or absence of clinically significant abnormal findings in physical examination, laboratory evaluations, 12-lead Electrocardiogram (ECG) and X-ray chest Postero-anterior (PA) view during screening.
5. Hemoglobin: ≥12.0 gm%.
6. Subjects without any evidence of impaired glucose tolerance in 2 hour Oral Glucose Tolerance Test (OGTT) at screening.
7. Absence of disease markers of HIV I & II, a negative P24 antigen test, negative Hepatitis B Surface Antigen (HBsAg) and Hepatitis C
Virus Antibody (HCVAb).
8. Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.
9. Negative breath alcohol test at every check-in.
10. Negative urine drug abuse test (barbiturates, benzodiazepines,
opioids, cocaine, cannabinoids and amphetamine, etc.) at every check-in. (This test will be done at the clinical facility).
Exclusion Criteria
1. History / evidence of allergy or hypersensitivity to any drug
2. Any major illness in the last three months or any significant ongoing chronic medical illness
3. Recent history or presence of active kidney or liver dysfunction.
4. Active deep vein thrombosis, pulmonary embolism, arterial thromboembolic disorders or a history of these conditions.
5. History of or current gastrointestinal diseases influencing drug absorption
6. History of drug abuse (including barbiturates, benzodiazepines,
opioids, cocaine, cannabinoids and amphetamine etc.) within last 3 months.
7. History of hyperglycaemia (symptoms include nausea, vomiting,drowsiness, flushed dry skin, dry mouth, increased frequency of urination, thirst and loss of appetite as well as acetone breath).
8. History of diabetic ketoacidosis.
9. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes
fainting).
10. A history of neuropsychiatric diseases.
11. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the start of
the study.
12. History or presence of asthma, urticaria or other allergic reactions.
13. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
14. History or presence of cancer.
15. Consumption of xanthine-containing food and beverages (chocolates, tea, coffee or cola drinks) and tobacco products (Gutka or Pan masala) 48.00 hours prior to check-in.
16. Consumption of grapefruit, grapefruit juice/ products and poppy-containing food and beverages within at least 48.00 hours prior to every check-in.
17. History of difficulty with donating blood or difficulty in accessibility ofveins in left or right arm.
18. Donation of blood (1 unit) within 90 days prior to the first dose of the study drug or have blood loss, excluding volume drawn at screening (more than 100 ml within 30 days; more than 200 ml within 60 days) prior to first dose of the study or have received a known investigational drug within five elimination half-lives of the administered drug prior to the first dose of the study drug.
19. Use of any prescription drug therapy within two weeks and overthe- counter (OTC) drugs or herbal products within one week prior to receiving the dose of study medication and during the study [these include thiazolidinediones, oral hypoglycaemic agents (OHAs), monoamine oxidase inhibitors (MAOIs), non-selective betaadrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors,salicylates, anabolic steroids (except danazol and oxymetholone), alpha-adrenergic blocking agents, quinine,quinidine, sulphonamides, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone, diazoxide, asparaginase, nicotinic acid, oxymetholone, danazol, beta blockers,
octreotide and lanreotide].
ExclusionCriteria
Details
1. Allergy or significant history of hypersensitivity or idiosyncratic reaction to E.coli-derived proteins‚ G-CSF or any other excipients in the particular product.
2. Cardiovascular, pulmonary, hepatic, renal, hematological, endocrinal, gastrointestinal, immunologic, dermatologic, neurological or psychiatric disease.
3. Having systolic blood pressure <100 and >130 mmHg, diastolic blood pressure <60 and >88 mmHg and pulse rate <60 and >100
4. Subjects who have been on an unusual diet (for whatever reason, less than 200 kilocalories (kcal) and more than 3000 kcal during the four weeks preceding the study
5. Use of drugs which may potentiate the release of neutrophils‚ such as lithium‚ in the previous 30 days before the study.
6. Female subjects who are currently breast feeding or pregnant or post menopausal (by history or as evidenced by hormonal results)
Method of Generating Random Sequence
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
To demonstrate equivalence of PK and PD characteristics of G-CSF of Biogenomics and Neupogen® after multiple SC injections in healthy adult human volunteers.
PK-18
PD ANC-16 and CD34-5
Secondary Outcome
Outcome
TimePoints
To compare the safety profile and local tolerance of G-CSF of BGL and Neupogen® after multiple SC injections in healthy adult human volunteers
Throughout the study
Target Sample Size
Total Sample Size="64" Sample Size from India="64" Final Enrollment numbers achieved (Total)= "59" Final Enrollment numbers achieved (India)="59"
Phase of Trial
Phase 1
Date of First Enrollment (India)
05/04/2016
Date of Study Completion (India)
05/07/2016
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
None yet
Data still under review. After finalization, we will update the status
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A phase I, single-centre, randomized, double-blind, two-treatment, two-period, two-sequence, two-way crossover study to demonstrate equivalence of Pharmacokinetic and Pharmacodynamic characteristics and to compare safety and tolerability of Granulocyte Colony Stimulating Factor (BioGenomics Limited) and Neupogen® administered via subcutaneous route as multiple consecutive doses in healthy adult human volunteers