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In local healthy human volunteers after single subcutaneous dose of 20 kDa peginteferon -2a (from Unipeg) evaluation of safety and pharmacokinetics of the drug

Protocol summary

Summary
Study Title: Pharmacokinetic and Safety evaluation of pegylated interferon α-2a from its commercial product “Unipeg” in healthy human subjects. Study goal: To establish the Pharmacokinetic and safety of 20 kDa peginterferon (Unipeg) in Pakistani population. Study Design: Open label, single period, single treatment, and single dose study in healthy volunteers. Sample size: Ten Inclusion Criteria: Healthy male subjects, Age: 18-45 years, BMI: 18-26 kg/m2, Able to understand and give free written informed consent, Non-smoker, non-alcoholic Exclusion criteria: any illness, blood donation in last two months, OTC and any prescription drug in last 14 and 30 days respectively. Participation in another study within last 2 months Treatments: After 10 hour fasting; single dose of PEG-interferon alfa-2a 180mcg administered subcutaneously in the morning in abdominal region. 5ml blood was collected at 0, 1, 2, 3, 6, 12, 24, 36, 60, 84, 108, 132, & 156 hours after drug administration. Safety: through physical examination, vital sign, adverse events and lab test monitoring on screening, fifth day and at follow up after two weeks. CBC and ALT test for safety on day five and sixteen. Analysis: through ELISA Pharmacokinetics analysis: PK Parameters; AUC0–t, AUC0–∞, Cmax, Tmax and T1/2. determined by model independent method using PK-solution and PP-stat software Ethical consideration: Approved from independent ethics committee of ICCBS, University of Karachi, and full compliance to Declaration of Helsinki and ICH-GCP.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111027978N1
Registration date: 2012-02-11, 1390/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-11, 1390/11/22
Registrant information
Name
Tasneem Ahmad
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Country
Pakistan
Phone
(92-21) 34972358, 34820573
Email address
tasneem.ahmed@iccs.edu
Recruitment status
Recruitment complete
Funding source
Getz Pharma (Pvt) Ltd; Karachi, Pakistan
Expected recruitment start date
2010-07-21, 1389/04/30
Expected recruitment end date
2010-08-05, 1389/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In local healthy human volunteers after single subcutaneous dose of 20 kDa peginteferon -2a (from Unipeg) evaluation of safety and pharmacokinetics of the drug
Public title
A STUDY OF UNIPEG® IN HEALTHY HUMAN SUBJECTS TO EVALUATE ITS SAFETY AND PHARMACOKINETIC BEHAVIOUR
Purpose
Other
Inclusion/Exclusion criteria
INCLUSION: Healthy human volunteers, BMI: 18-26 Kg/m2, non-smoker, non-alcoholic, with normal lab reports for CBC, LFT, HBsAg, Anti HCV, HIV antibody EXCLUSION: • Any active allergic disease or a history of significant allergic disease. • Presence of renal, hepatic or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination with in last year. • Subject demonstrates protocol non-compliance (e.g. uncooperative attitude, & inability to finish study). • Participation in another study within last 2 months of 1st drug administration. • If donated blood within last 2 months preceding the study. • Age below 18 years and above 45yr. • Smoking within last 3 months prior to the drug administration and 6 hours after drug administration. • Ingestion of OTC drug (except Paracetamol) within last 14 days of 1st drug administration. • Participants with insufficient organ and/or bone marrow dysfunction. • Ingestion of investigational drug within 1 year prior to 1st drug administration. • Participants with low blood counts and hematology results outside the normal range. (ANC) absolute neutrophile count should be > 1500/mm3 and platelete count should be grater then 50,000/ mm3 . • Participants with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study. • Participants with any physical/mental disability • Subjects with known HIV, hepatitis B or hepatitis C infection, or autoimmune diseases. • History of major organ transplantation, new onset diabetes, unstable thyroid function. • Concurrent therapy with immunosuppressive drugs or cytotoxic agents. • Alcohol or drug abuse within the past year. • Known hypersensitivity to investigational drug • Participants with uncontrolled brain metastases or central nervous system disease. • Strenuous physical activity performed within 48 hours before drug administration and during study. • Positive drug of abuse test and alcohol test. • Intake of gutka, pan and any other thing containing nicotine 48 hours before and during study. • Volunteer with thyroid dysfunction.
Age
From 18 years old to 45 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

1

Registry name
Iranian Registry of Clinical Trials (IRCT)
Secondary trial Id
CB-002-PEG-2010
Registration date
2012-01-16, 1390/10/26

Ethics committees

1

Ethics committee
Name of ethics committee
Independent Ethics Committee of International Center for Chemical and Biological Sciences (ICCBS); P
Street address
University of Karachi
City
Karachi
Postal code
75270
Approval date
2010-07-09, 1389/04/18
Ethics committee reference number
ICCBS/IEC/Lett-17/10

Health conditions studied

1

Description of health condition studied
Chronic viral hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Viral Hepatitis

Primary outcomes

1

Description
Serum levels of peginterferon α-2a Pharmacokinetic parameters: Cmax, Tmax, AUC0-t, AUC0-∞, T1/2,
Timepoint
At 0, 1, 2, 3, 6, 12, 24, 36, 60, 84, 108, 132 and 156 hours
Method of measurement
• Serum concentration measured by Enzyme-linked immunosorbent assay (ELISA). • Pharmacokinetic (PK) parameter will be determined on the basis of measurement of concentration; performed by means of model independent method using Pk-solution and PPstat computer programs. • Elimination half-life (T1/2) calculated as 0.693 /k. • Area under the curve to the last measurable concentration (AUC) 0-t) will be calculated by the linear trapezoidal rule. Area under the curve extrapolated to infinity (AUCo-inf) will be calculated as AUC0-t + Ct /k, where Ct is the last measurable concentration.

Secondary outcomes

1

Description
Safety as measured by the frequency and intensity of adverse events (AEs), vital signs measurement, Lab tests: effect on neutrophils, total leukocytes count, absolute neutrophil counts, Hb levels, ALT levels.
Timepoint
Adverse events Monitoring: throughout study period (two weeks) Vital sign measurement: at time 0, 1, 2, 4, 8, 12, 24, 36, 60, 84, 108, 132, & 156hours. 0 to 156 hours Lab tests: within two weeks before drug administration (Baseline), on day five (during study) and day sixteen of drug administration (at follow up visit)
Method of measurement
By measuring the frequency and intensity of Standard Pharmacokinetic analysis of Serum level profileadverse event. For lab tests: comparing the day five and sixteen results with baseline results and calculated the p-value at 5% level of significance.

Intervention groups

1

Description
Peginterferon α-2a; 180 µg single dose; subcutaneously in abdominal region.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Bioequivalence Studies and Bioassay Research
Full name of responsible person
Prof. Dr. Tasneem Ahmad
Street address
CBSBR at ICCBS University of Karachi
City
Karachi

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Getz Pharma (Pvt) Limited
Full name of responsible person
Dr. Khawar Mehdi
Street address
Director Medical Affairs, 29-30, Secotr-27, Korangi Industrial Area
City
Karachi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Getz Pharma (Pvt) Limited
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Full name of responsible person
Ms. Ghousia Saba
Position
Manager Clinical Services/ B.Pharm
Other areas of specialty/work
Street address
8 Gulshan View, Gulshan-e-Iqbal, Karachi,
City
Karachi
Province
Sind
Postal code
75300
Phone
009221-34972358
Fax
Email
ghousia@phaps.com
Web page address
www.phaps.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Center for Bioequivalence Studies and Bioassay Research (CBSBR), International Center for Chemical a
Full name of responsible person
Prof. Dr. Tasneem Ahmad
Position
Ph.D.
Other areas of specialty/work
Street address
CBSBR at ICCBS, University of Karachi
City
Karachi
Province
Sind
Postal code
75300
Phone
009221-111222292
Fax
Email
tasneem.ahmed@iccs.edu
Web page address
www.iccs.edu

Person responsible for updating data

Contact
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Full name of responsible person
Ms. Ghousia Saba
Position
Manager Clinical Services/ B.Pharm
Other areas of specialty/work
Street address
8 Gulshan View, Gulshan-e-Iqbal, Karachi,
City
Karachi
Province
-Sind
Postal code
75300
Phone
00922134972358
Fax
Email
ghousia@phaps.com
Web page address
www.phaps.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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