Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

This study has been completed.
Information provided by (Responsible Party):
Albany College of Pharmacy and Health Sciences Identifier:
First received: March 20, 2012
Last updated: July 19, 2012
Last verified: March 2012
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
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 Albany College of Pharmacy and Health Sciences:

Primary Outcome Measures:
  • Serum and Urine Concentration Time Profile [ Time Frame: Over 96 hours ] [ Designated as safety issue: Yes ]
    To characterize the single dose serum and urine concentration-time profile of single dose intravenous tigecycline in obese class III and normal weight subjects

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
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01560143

United States, New York
Albany College of Pharmacy
Albany, New York, United States, 12186
Sponsors and Collaborators
Albany College of Pharmacy and Health Sciences
Principal Investigator: Manjunath P Pai, PharmD Albany College of Pharmacy and Health Sciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Albany College of Pharmacy and Health Sciences Identifier: NCT01560143     History of Changes
Other Study ID Numbers: 11-007  WS2001231 
Study First Received: March 20, 2012
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 26, 2016