Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 118 for:    oseltamivir

Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01179919
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : December 6, 2016
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Manjunath Prakash Pai, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Obesity
Intervention Drug: Oseltamivir
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oseltamivir Dosed Group
Hide Arm/Group Description

Oseltamivir 75 mg by mouth every 12 hours for 9 doses

Oseltamivir: Capsule, 75 mg by mouth for 9 doses

Period Title: Overall Study
Started 21
Completed 19
Not Completed 2
Reason Not Completed
Protocol Violation             1
Adverse Event             1
Arm/Group Title Oseltamivir Dosed Group
Hide Arm/Group Description

Oseltamivir 75 mg by mouth every 12 hours for 9 doses

Oseltamivir: Capsule, 75 mg by mouth for 9 doses

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
Subjects administered at least 1 dose of oseltamivir
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
36
(19 to 50)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
17
  81.0%
Male
4
  19.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  33.3%
White
11
  52.4%
More than one race
3
  14.3%
Unknown or Not Reported
0
   0.0%
Body Mass Index  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 21 participants
43.7
(40.0 to 54.4)
1.Primary Outcome
Title Steady-State AUC of Oseltamivir Carboxylate
Hide Description AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour*ng/mL)
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received all 9 doses of oseltamivir
Arm/Group Title Oseltamivir Dosed Group
Hide Arm/Group Description:

Oseltamivir 75 mg by mouth every 12 hours for 9 doses

Oseltamivir: Capsule, 75 mg by mouth for 9 doses

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: hour*ng/mL
2579  (510)
2.Secondary Outcome
Title Steady-State Cmax and Cmin of Oseltamivir Carboxylate
Hide Description Cmax is the maximum concentration and Cmin in the minimum concentration of oseltamivir carboxylate measured in nanogram of oseltamivir carboxylate per milliliter of plasma (ng/mL)
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received all 9 doses of oseltamivir
Arm/Group Title Oseltamivir Dosed Group
Hide Arm/Group Description:

Oseltamivir 75 mg by mouth every 12 hours for 9 doses

Oseltamivir: Capsule, 75 mg by mouth for 9 doses

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax 316  (68.1)
Cmin 113  (37.4)
Time Frame 6 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oseltamivir Dosed Group
Hide Arm/Group Description

Oseltamivir 75 mg by mouth every 12 hours for 9 doses

Oseltamivir: Capsule, 75 mg by mouth for 9 doses

All-Cause Mortality
Oseltamivir Dosed Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oseltamivir Dosed Group
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oseltamivir Dosed Group
Affected / at Risk (%) # Events
Total   1/21 (4.76%)    
General disorders   
Anxiety *  1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
This study only evaluated obese subjects. The concentrations measured in plasma may not reflect concentrations in tissues such as the lungs.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manjunath Pai
Organization: University of Michigan
Phone: 7346473466
EMail: amitpai@med.umich.edu
Layout table for additonal information
Responsible Party: Manjunath Prakash Pai, University of Michigan
ClinicalTrials.gov Identifier: NCT01179919     History of Changes
Other Study ID Numbers: 10-002
First Submitted: August 10, 2010
First Posted: August 11, 2010
Results First Submitted: October 11, 2016
Results First Posted: December 6, 2016
Last Update Posted: February 9, 2017