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Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

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ClinicalTrials.gov Identifier: NCT01560143
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : December 6, 2016
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Manjunath Prakash Pai, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Tigecycline Phase 4

Detailed Description:
Not required

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline

Arm Intervention/treatment
Tigecycline
All subjects receive a single dose of tigecycline
Drug: Tigecycline
100 mg IV as a single infusion over 30 minutes
Other Name: Tygacil




Primary Outcome Measures :
  1. Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours [ Time Frame: 4 days (96 hours) ]
    The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560143


Locations
United States, New York
Albany College of Pharmacy
Albany, New York, United States, 12186
Sponsors and Collaborators
Manjunath Prakash Pai
Pfizer
Investigators
Principal Investigator: Manjunath P Pai, PharmD University of Michigan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manjunath Prakash Pai, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01560143     History of Changes
Other Study ID Numbers: 11-007
WS2001231 ( Other Grant/Funding Number: Pfizer, Inc. )
First Posted: March 22, 2012    Key Record Dates
Results First Posted: December 6, 2016
Last Update Posted: February 9, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data have been published as a manuscript J Antimicrob Chemother. 2014 Jan;69(1):190-9.

Additional relevant MeSH terms:
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents