Clinical trial NCT01002729: Oseltamivir Pharmacokinetics in Morbid Obesity
Official title: Oseltamivir Pharmacokinetics in Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Oseltamivir Pharmacokinetics Obesity
Oseltamivir Pharmacokinetics in Obesity
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Center for Vaccinology
name: Nova Scotia Health Authority
name: Dalhousie University
name: Hoffmann-La Roche
First posted: 2009-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 have influenza, and currently is also being used to fight the new H1N1 influenza. Some people of larger than average body weight require larger amounts of drugs to see the same effects as others of an average body weight. No studies have ever been conducted looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis states that those of an above average body weight will have different amounts of drug in their blood than those of people of normal body weight if they are given the normal amount prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half of the people will be of normal body weight and the others will be of a much higher than normal body weight. Using blood samples the investigators will determine if the amounts of oseltamivir are significantly lower in the blood of patients in the above normal body weight group.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Serum Drug Concentration
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Human Vaccine Challenge Unit, IWK Health Center
state: Nova Scotia
Study officials:
affiliation: Dalhousie Unviersity, Captial District Health Authority
name: Lucas M Thorne-Humphrey, BSC Pharm
role: STUDY_CHAIR
References:
citation: Thorne-Humphrey LM, Goralski KB, Slayter KL, Hatchette TF, Johnston BL, McNeil SA; 2009 OPTIMO Study Group. Oseltamivir pharmacokinetics in morbid obesity (OPTIMO trial). J Antimicrob Chemother. 2011 Sep;66(9):2083-91. doi: 10.1093/jac/dkr257. Epub 2011 Jun 23.