Status:
COMPLETED
Oseltamivir Pharmacokinetics in Morbid Obesity
Lead Sponsor:
IWK Health Centre
Collaborating Sponsors:
Canadian Center for Vaccinology
Nova Scotia Health Authority
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This trial asks the question: do people of much greater than average body weight need more of a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given to people who ...
Eligibility Criteria
Inclusion
- Males and females aged 18 to 55 years
- Written informed consent
- Subjects without medical history, physical finding or laboratory finding, which, in the opinion of the investigator, could pose a safety concern or interfere with the protocol.
Exclusion
- Allergy to oseltamivir
- Blood donation within 3 months before oseltamivir administration
- Medications that may interfere with the disposition of oseltamivir (e.g. probenecid)
- Anemia
- Estimated Creatinine clearance \< 60 ml/min (As calculated by the modified Cockcroft Gault equation below) Creatinine Clearance= (140-Age) x 1.2 x Adjusted Body weight (x 0.85 if female) Serum Creatinine (umol/L)
- Adjusted body weight = Ideal body weight + \[0.4 (Actual Bodyweight-Ideal Body Weight)\]
- Gastrectomy
- Enterectomy (or any other surgical procedure that would interfere with absorption)
- Clinically significant haematological (RBC count, WBC count, WBC differential count, platelets count and haemoglobin level) or biochemical (ALT, AST, creatinine and urea) abnormalities as per the judgement of the investigator
- Clinically significant cardiac conduction abnormality noted on baseline electrocardiogram.
- Influenza like illness (fever and/or cough plus one of the following sore throat, fatigue, myalgia, headache) within 7 days of enrolment
- Pregnancy
- Inability to consume study meals provided due to special dietary requirements such as food allergies.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01002729
Start Date
November 1 2009
End Date
December 1 2009
Last Update
August 3 2011
Active Locations (1)
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1
Human Vaccine Challenge Unit, IWK Health Center
Halifax, Nova Scotia, Canada, B3K 6R8