A Pharmacokinetic And Safety Study Of Voriconazole In Hea... | NCT00855101

Studies
A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults

NCT00855101

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jun 14, 2010Estimated

Enrollment

35Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

voriconazole

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Mar 2, 2009

First Submission Date that Met QC Criteria

Mar 2, 2009

First Posted Date

Mar 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2010

Last Update Posted Date

Jun 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to assess the plasma concentration-time profile of voriconazole in adults receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to assess the safety profile of voriconazole during the treatment period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
voriconazole	Experimental		Drug: voriconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
voriconazole	Drug	6 mg/kg IV q12h on Day 1, and 4 mg/kg IV q12h on Days 2-7, then switch to 200 mg oral tablet q12h on Days 8-14.	voriconazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults		14 days

Secondary Outcomes

Measure	Description	Time Frame
The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects from 18 and 55 years old.
Body weight between 40 kg (88 lbs) and 100 kg (220 lbs).

Exclusion Criteria:

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, ocular, neurologic, or allergic disease.
Subjects with any condition possibly affecting drug absorption, eg, gastrectomy.
Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Brussels		1070	Belgium

References Module

Citations

Not provided

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds