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CompletedNCT01002729OPTIMOUpdated Aug 3, 2011

Oseltamivir Pharmacokinetics in Morbid Obesity

An interventional study of Patients with a BMI < 30 given Oseltamivir and Patients with a BMI > 40 given Oseltamivir in Morbid Obesity, sponsored by IWK Health Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-03.

Sponsored by IWK Health Centre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

02

Conditions studied

  • Morbid Obesity

Keywords

  • Oseltamivir Pharmacokinetics Obesity
  • Oseltamivir Pharmacokinetics in Obesity
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 20 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

IWK Health Centre is the lead sponsor of 83 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Interventions

  • OtherPatients with a BMI < 30 given Oseltamivir

    Patients with a BMI \< 30 given Oseltamivir

  • OtherPatients with a BMI > 40 given Oseltamivir

    Patients with a BMI \> 40 given Oseltamivir

06

What researchers measure

Primary outcomes

  1. Serum Drug Concentration

    Time frame: 7 Days

07

Study locations

1 site
  • Human Vaccine Challenge Unit, IWK Health Center
    Halifax, Nova Scotia B3K 6R8, Canada
08

References and documents

Publications

  • 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. PubMed 21700623 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01002729
Lead sponsor
IWK Health Centre
Collaborators
Canadian Center for Vaccinology, Nova Scotia Health Authority, Dalhousie University, Hoffmann-La Roche
First posted
Oct 27, 2009
Start date
Nov 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Aug 3, 2011

Study contacts

Lucas M Thorne-Humphrey, BSC Pharm
study chair · Dalhousie Unviersity, Captial District Health Authority

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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