Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

NCT01560143 | Completed Phase 4 Results

• 2 other identifiers: 11-007WS2001231
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Single-dose Serum AUC of Tigecycline Between Time 0 and 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)

  4 days (96 hours)

Study Arms (1)

Tigecycline

OTHER

All subjects receive a single dose of tigecycline

Drug: Tigecycline

Interventions

Tigecycline DRUG

100 mg IV as a single infusion over 30 minutes

Also known as: Tygacil

Tigecycline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects fulfilling the following criteria will be eligible:
• males and females, 18 to 50 years of age;
• non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
• Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
• 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

You may not qualify if:

• history of significant hypersensitivity reaction to any components of Tygacil®;
• history of significant clinical illness requiring pharmacological management;
• history of blood donation in the past eight week period;
• abnormal serum electrolyte or complete blood count requiring further clinical work-up;
• transaminases (AST or ALT) \> 2.5 x upper limit of normal;
• subjects with stage 4 or 5 chronic kidney disease;
• positive serum pregnancy test (if female);
• abnormal electrocardiogram (ECG) as judged by study physician;
• unable to tolerate venipuncture and multiple blood draws;
• clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
• unable to independently provide a written informed consent.

Sponsors & Collaborators

• Manjunath Prakash Pai: lead
• Pfizer: collaborator

Study Sites (1)

Albany College of Pharmacy

Albany, New York, 12186, United States

Location

Related Publications (1)

• 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.

  PMID: 23883872 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Small study sample size

Results Point of Contact

• Title: Manjunath Pai
• Organization: University of Michigan

amitpai@med.umich.edu

7346473466

Study Officials

• Manjunath P Pai, PharmD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 9, 2017
• Results First Posted: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)