NCT01002729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

1 month

First QC Date

October 25, 2009

Last Update Submit

August 2, 2011

Conditions

Morbid Obesity

Keywords

Oseltamivir Pharmacokinetics ObesityOseltamivir Pharmacokinetics in Obesity

Outcome Measures

Primary Outcomes (1)

  • Serum Drug Concentration

    7 Days

Interventions

Patients with a BMI < 30 given OseltamivirOTHER

Patients with a BMI \< 30 given Oseltamivir

Patients with a BMI > 40 given OseltamivirOTHER

Patients with a BMI \> 40 given Oseltamivir

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Vaccine Challenge Unit, IWK Health Center

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21700623RESULT

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lucas M Thorne-Humphrey, BSC Pharm

    Dalhousie Unviersity, Captial District Health Authority

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2009

First Posted

October 27, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations

CA(1)