| CTRI Number |
CTRI/2018/02/011700 [Registered on: 05/02/2018] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study of Injections of Pegfilgrastim in Healthy, Adult Human Subjects. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 0553-17, Version: 2.0, Date: 02 December 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anshul Attrey |
| Designation |
Senior Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Plot no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202282 |
| Fax |
07940202021 |
| Email |
anshulattrey@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshul Attrey |
| Designation |
Senior Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Plot no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway, Gota
GUJARAT
382481
India |
| Phone |
07940202282 |
| Fax |
07940202021 |
| Email |
anshulattrey@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshul Attrey |
| Designation |
Senior Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Plot no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway, Gota
GUJARAT
382481
India |
| Phone |
07940202282 |
| Fax |
07940202021 |
| Email |
anshulattrey@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd,
Plot no 423/P/A, Sarkhej-Bavla highway
Village: Moraiya, Taluka: Sanand
Ahmedabad 382213, Gujarat, India
Tel. No.: 0792717-660100
Fax No.: 0792717660105
|
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
Plot no 423/P/A, Sarkhej-Bavla highway Village: Moraiya, Taluka: Sanand Ahmedabad 382213, Gujarat, India Tel. No.: 0792717-660100 Fax No.: 0792717660105 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anshul Attrey |
Lambda Therapeutic Research Ltd |
Lambda House, Plot no. 38, Survey No. 388 Near Silver Oak Club,
S. G. Highway, Gota
Ahmadabad
GUJARAT |
07940202282
07940202021
anshulattrey@lambda-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Conscience Independent Ethics Committee, Dr Anshul |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTP5 of Intas Pharmaceuticals Limited |
Dose:6 mg/0.6 ml; Frequency: Single
dose; Mode of Administration:
Subcutaneous;
Duration of treatment: One day |
| Comparator Agent |
Neulasta of Amgen Inc |
Dose:6 mg/0.6 ml; Frequency: Single dose; Mode of Administration: Subcutaneous; Duration of treatment: One day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. 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.
2. Having body weight greater than or equal to 50 kg and body mass index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/height in meter square.
3. 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 X-ray chest (P/A view; within the last 6 months) recordings.
4. Volunteer who is a Non-smoker
5. Able to understand and comply with the study procedures, in the opinion of the investigator.
6. Able to give voluntary written informed consent for participation in the trial.
7. In case of female subjects:
a. Surgically sterilized at least 6 months prior to study participation;
Or
If a woman of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
b. Serum pregnancy test (for female subjects) must be negative |
|
| ExclusionCriteria |
| Details |
1. 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
2. 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.
3. Known case of hereditary fructose intolerance
4. Subjects with latex allergies will be excluded as the needle cover on the single-use prefilled syringe contains dry natural rubber (latex).
5. Any clinically significant laboratory finding including ANC, platelet, RBC count or hemoglobin level at the time of screening.
6. 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.
7. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs-induced urticaria.
8. Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months.
9. History of any hematologic disease including sickle cell disorders.
10. Smokers, or who have smoked within last six months prior to start of the study.
11. Ingestion or use of any prescribed medication at any time within 1 month prior to receiving first dose in period I.
12. 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).
13. 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.
14. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
15. 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.
16. Positive result for human immunodeficiency virus (HIV I &/or II) and/or hepatitis B and C tests.
17. History or presence of cancer because of which anticipated life span is less than 5 years as per the investigator’s assessment.
18. History or presence of psychiatric disorders.
19. Presence of tattoo or scars or any type of skin lesions due to infection, burning, wound or inflammation at the proposed site of injection.
20. 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.
21. Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug in period-I.
22. A history of difficulty in donating blood.
23. Females, pregnant or lactating, or planning to become pregnant during the course of the study or found positive in pregnancy test at screening.
24. Any infections in the last 4 weeks before receiving study medication in period-I. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment and comparision of pharmacokinetic and pharmacodynamic profiles of INTP5 and Neulasta in healthy, adult, human subjects. |
For pharmacokinetic
Day 1 to Day 9, Day 11, Day 13, Day 15, Day 22 in each period
For pharmacodynamic
Day 1 to Day 11, Day 13 to Day 16, Day 22 in each period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment and comparision of safety and tolerability of INTP5 and Neulasta in healthy, adult, human subjects. |
Day 1 to end of study |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way, crossover, comparative subcutaneous injection (6 mg/0.6 ml) pharmacokinetic and pharmacodynamic study in healthy, adult, human subjects under fed conditions. The objective of this study is to assess and compare the pharmacokinetic and pharmacodynamic profiles as well as safety and tolerability of INTP5 and Neulasta after single subcutaneous dose administration of Pegfilgrastim in healthy, adult, human subjects. Through this study, we will prospectively collect the data on healthy subjects that are randomly assigned to receive INTP5 of Intas Pharmaceuticals Ltd., India or Neulasta of Amgen Inc, USA for the PK and PD profiling. No additional tests apart from those already specified in this protocol, will be performed. The study will therefore not place any additional risk/burden on the subjects. |