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Oseltamivir Pharmacokinetics in Morbid Obesity (OPTIMO)

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Patients with a BMI < 30 given Oseltamivir
Patients with a BMI > 40 given Oseltamivir
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Oseltamivir Pharmacokinetics Obesity, Oseltamivir Pharmacokinetics in Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Human Vaccine Challenge Unit, IWK Health Center

Outcomes

Primary Outcome Measures

Serum Drug Concentration

Secondary Outcome Measures

Full Information

First Posted
October 25, 2009
Last Updated
August 2, 2011
Sponsor
IWK Health Centre
Collaborators
Canadian Center for Vaccinology, Nova Scotia Health Authority, Dalhousie University, Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01002729
Brief Title
Oseltamivir Pharmacokinetics in Morbid Obesity
Acronym
OPTIMO
Official Title
Oseltamivir Pharmacokinetics in Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Center for Vaccinology, Nova Scotia Health Authority, Dalhousie University, Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Oseltamivir Pharmacokinetics Obesity, Oseltamivir Pharmacokinetics in Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Patients with a BMI < 30 given Oseltamivir
Intervention Description
Patients with a BMI < 30 given Oseltamivir
Intervention Type
Other
Intervention Name(s)
Patients with a BMI > 40 given Oseltamivir
Intervention Description
Patients with a BMI > 40 given Oseltamivir
Primary Outcome Measure Information:
Title
Serum Drug Concentration
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas M Thorne-Humphrey, BSC Pharm
Organizational Affiliation
Dalhousie Unviersity, Captial District Health Authority
Official's Role
Study Chair
Facility Information:
Facility Name
Human Vaccine Challenge Unit, IWK Health Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21700623
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.
Results Reference
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Oseltamivir Pharmacokinetics in Morbid Obesity

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