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Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Manjunath Prakash Pai, University of Michigan
ClinicalTrials.gov Identifier:
NCT01560143
First received: March 20, 2012
Last updated: October 11, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Obesity
Drug: Tigecycline
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours [ Time Frame: 4 days (96 hours) ] [ Designated as safety issue: No ]
    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)


Enrollment: 12
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tigecycline
All subjects receive a single dose of tigecycline
Drug: Tigecycline
100 mg IV as a single infusion over 30 minutes
Other Name: Tygacil

Detailed Description:
Not required
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: March 20, 2012
Results First Received: October 11, 2016
Last Updated: October 11, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 08, 2016