Chronic viral hepatitis C. Viral Hepatitis
Conditions
Interventions
Peginterferon a-2a
180 µg single dose
subcutaneously in abdominal region..
Treatment - Drugs
subcutaneously in abdominal region.
Sponsors
Getz Pharma (Pvt) Limited
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Pakistan
Contacts
Public ContactMs. Ghousia Saba
Pharma Professional Services, Karachi, Pakistan
Outcome results
None listed