NCT01560143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

December 6, 2016

Completed
Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

March 20, 2012

Results QC Date

October 11, 2016

Last Update Submit

December 16, 2016

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

TigecyclineDRUG

100 mg IV as a single infusion over 30 minutes

Also known as: Tygacil
Tigecycline

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 23883872DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic 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

The data have been published as a manuscript J Antimicrob Chemother. 2014 Jan;69(1):190-9.

Locations

US(1)