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Oseltamivir Pharmacokinetics in Morbid Obesity (OPTIMO)

This study has been completed.
Sponsor:
Collaborators:
Canadian Center for Vaccinology
Capital District Health Authority, Canada
Dalhousie University
Hoffmann-La Roche
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01002729
First received: October 25, 2009
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Morbid Obesity
 Other: Patients with a BMI < 30 given Oseltamivir
Other: Patients with a BMI > 40 given Oseltamivir

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oseltamivir Pharmacokinetics in Morbid Obesity

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Serum Drug Concentration [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Patients with a BMI < 30 given Oseltamivir
    Patients with a BMI < 30 given Oseltamivir
    Other: Patients with a BMI > 40 given Oseltamivir
    Patients with a BMI > 40 given Oseltamivir
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002729

Locations
Canada, Nova Scotia
Human Vaccine Challenge Unit, IWK Health Center
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Center for Vaccinology
Capital District Health Authority, Canada
Dalhousie University
Hoffmann-La Roche
Investigators
Study Chair: Lucas M Thorne-Humphrey, BSC Pharm Dalhousie Unviersity, Captial District Health Authority
  More Information

Publications:

Responsible Party: McNeil, Shelly, IWK Health Sciences Center / Capital Distict Health Authority
ClinicalTrials.gov Identifier: NCT01002729     History of Changes
Other Study ID Numbers: RC91
Study First Received: October 25, 2009
Last Updated: August 2, 2011
Health Authority: Canada: Health Canada, Therapeutic Products Directorate

Keywords provided by IWK Health Centre:
Oseltamivir Pharmacokinetics Obesity
Oseltamivir Pharmacokinetics in Obesity

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013