NCT00855101

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2009

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

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 14, 2010

Status Verified

June 1, 2010

Enrollment Period

3 months

First QC Date

March 2, 2009

Last Update Submit

June 11, 2010

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics and safety of voriconazole intravenous oral adults

Outcome Measures

Primary Outcomes (1)

  • The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults

    14 days

Secondary Outcomes (1)

  • The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults

    14 days

Study Arms (1)

voriconazole

EXPERIMENTAL
Drug: voriconazole

Interventions

voriconazoleDRUG

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.

Also known as: Vfend
voriconazole

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 14, 2010

Record last verified: 2010-06

Locations

BE(1)