NCT01062165

Brief Summary

This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 21, 2013

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

February 2, 2010

Results QC Date

December 13, 2012

Last Update Submit

December 21, 2016

Conditions

ObesityFungal Infection

Keywords

EchinocandinObesityPharmacokineticsPharmacodynamicsFungal infection

Outcome Measures

Primary Outcomes (1)

  • Total Clearance of Caspofungin

    0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)

Study Arms (1)

Capsofungin

EXPERIMENTAL

Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.

Drug: Caspofungin

Interventions

CaspofunginDRUG

Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)

Also known as: Cancidas
Capsofungin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.

You may not qualify if:

  • Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, so that the pregnancy and post-partum state would be a confounding variable.
  • Abnormal liver function tests: transaminases\>10 times upper limit of normal, Alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal.
  • History of allergies to echinocandins.
  • Echinocandins are contraindicated for any reason.
  • Volunteers unwilling to comply with study procedures.
  • Suspected or documented systemic fungal infection.
  • Concomitant use of rifamycins, tacrolimus, or cyclosporine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Hall RG 2nd, Swancutt MA, Meek C, Leff R, Gumbo T. Weight drives caspofungin pharmacokinetic variability in overweight and obese people: fractal power signatures beyond two-thirds or three-fourths. Antimicrob Agents Chemother. 2013 May;57(5):2259-64. doi: 10.1128/AAC.01490-12. Epub 2013 Mar 4.

    PMID: 23459494RESULT

MeSH Terms

Conditions

ObesityMycoses

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Results Point of Contact

Title
Ronald Hall
Organization
Texas Tech UHSC
ronald.hall@ttuhsc.edu
214-654-9404

Study Officials

  • Ronald Hall, PharmD, MSCS

    Texas Tech University HSC

    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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 4, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 10, 2017

Results First Posted

January 21, 2013

Record last verified: 2016-12

Locations

US(1)