Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

NCT01560143

Last updated date
Study Location
Albany College of Pharmacy
Albany, New York, 12186, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects fulfilling the following criteria will be eligible:

1. males and females, 18 to 50 years of age;

2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;

3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);

4. female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. history of significant hypersensitivity reaction to any components of Tygacil®;


2. history of significant clinical illness requiring pharmacological management;


3. history of blood donation in the past eight week period;


4. abnormal serum electrolyte or complete blood count requiring further clinical work-up;


5. transaminases (AST or ALT) > 2.5 x upper limit of normal;


6. subjects with stage 4 or 5 chronic kidney disease;


7. positive serum pregnancy test (if female);


8. abnormal electrocardiogram (ECG) as judged by study physician;


9. unable to tolerate venipuncture and multiple blood draws;


10. clinically significant abnormal physical examination defined as a physical finding
requiring further clinical work-up;


11. unable to independently provide a written informed consent.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Official Title  ICMJE Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Brief Summary If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight.
Detailed Description Not required
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Obesity
Intervention  ICMJE Drug: Tigecycline
100 mg IV as a single infusion over 30 minutes
Other Name: Tygacil
Study Arms  ICMJE Tigecycline
All subjects receive a single dose of tigecycline
Intervention: Drug: Tigecycline
Publications * Pai MP. Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults. J Antimicrob Chemother. 2014 Jan;69(1):190-9. doi: 10.1093/jac/dkt299. Epub 2013 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects fulfilling the following criteria will be eligible:

  1. males and females, 18 to 50 years of age;
  2. non-smoking or light-smoking (? 5 cigarettes per day) volunteers;
  3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ? 40 kg/m2 (obese class III);
  4. female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

Exclusion Criteria:

  1. history of significant hypersensitivity reaction to any components of Tygacil®;
  2. history of significant clinical illness requiring pharmacological management;
  3. history of blood donation in the past eight week period;
  4. abnormal serum electrolyte or complete blood count requiring further clinical work-up;
  5. transaminases (AST or ALT) > 2.5 x upper limit of normal;
  6. subjects with stage 4 or 5 chronic kidney disease;
  7. positive serum pregnancy test (if female);
  8. abnormal electrocardiogram (ECG) as judged by study physician;
  9. unable to tolerate venipuncture and multiple blood draws;
  10. clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
  11. unable to independently provide a written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01560143
Other Study ID Numbers  ICMJE 11-007
WS2001231 ( Other Grant/Funding Number: Pfizer, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:The data have been published as a manuscript J Antimicrob Chemother. 2014 Jan;69(1):190-9.
Responsible Party Manjunath Prakash Pai, University of Michigan
Study Sponsor  ICMJE Manjunath Prakash Pai
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Manjunath P Pai, PharmDUniversity of Michigan
PRS Account University of Michigan
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP