A STUDY OF UNIPEG® IN HEALTHY HUMAN SUBJECTS TO EVALUATE ITS SAFETY AND PHARMACOKINETIC BEHAVIOUR

Phase 4

• Conditions: Chronic viral hepatitis C.; Viral Hepatitis

• Registration Number: IRCT201111027978N1
• Lead Sponsor: Getz Pharma (Pvt) Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 10

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of peginterferon a-2a Pharmacokinetic parameters: Cmax, Tmax, AUC0-t, AUC0-8, 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 Outcome Measures

Name	Time	Method
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.