Oseltamivir Pharmacokinetics in Morbid Obesity

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Vaccine Challenge Unit, IWK Health Center

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients with a BMI < 30 given Oseltamivir

Other

Patients with a BMI < 30 given Oseltamivir

Patients with a BMI > 40 given Oseltamivir

Other

Patients with a BMI > 40 given Oseltamivir

Primary outcomes

Serum Drug Concentration

Time frame: 7 Days

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

Canadian Center for Vaccinology
Dalhousie University
Hoffmann-La Roche
Nova Scotia Health Authority

Registry information

Acronym: OPTIMO

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Oct 27, 2009
Registry last updated: Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed