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A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00940017
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : February 9, 2010
Last Update Posted : February 9, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Aspergillosis
Candidemia
Intervention Drug: anidulafungin and voriconazole
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Period Title: Overall Study
Started 24
Subjects Treated 21
Completed 20
Not Completed 4
Reason Not Completed
did not meet entrance criteria             3
Adverse Event             1
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
27.3  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
5
  20.8%
Male
19
  79.2%
1.Primary Outcome
Title Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
Hide Description Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL). Observed directly from the data. Collected on Day 3.
Time Frame 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ug/mL
Anidulafungin 6.56  (1.62)
Voriconazole 5.32  (1.82)
2.Primary Outcome
Title Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)
Hide Description Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. Collected on Day 3.
Time Frame 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: hours
Anidulafungin
1.93
(1.70 to 2.17)
Voriconazole
1.74
(1.67 to 2.05)
3.Primary Outcome
Title Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)
Hide Description AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL). Collected on Day 3.
Time Frame 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ug*hr/mL
Anidulafungin 101  (21.8)
Voriconazole 39.5  (19.8)
4.Primary Outcome
Title Plasma PK: Plasma Elimination Half-life (t1/2)
Hide Description t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Collected on Day 3.
Time Frame 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; (n) = number of subjects contributing to the mean
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: hours
Anidulafungin (n=18) 20.8  (3.06)
Voriconazole (n=15) 6.94  (2.10)
5.Primary Outcome
Title Plasma PK: Total Clearance (CL Total)
Hide Description CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min). Collected on Day 3.
Time Frame 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: mL/min
Anidulafungin 17.1  (3.04)
Voriconazole 172  (86.2)
6.Primary Outcome
Title Plasma PK: Volume of Distribution at Steady-state (Vss)
Hide Description Vss = volume of distribution at steady-state; measured as liters (L). Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]). MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.
Time Frame 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; (n) = number of subjects contributing to the mean.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: L
Anidulafungin (n=18) 30.8  (6.84)
Voriconazole (n=15) 110  (34.0)
7.Primary Outcome
Title Epithelial Lining Fluid (ELF) PK: Cmax
Hide Description Cmax=maximum observed plasma concentration. ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL]. Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected. Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: average concentration (ug/mL)
Anidulafungin 1.13
Voriconazole 48.3
8.Primary Outcome
Title ELF PK: Tmax
Hide Description Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. ELF collected by bronchoscopy and BAL on Day 3.
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: hours
Anidulafungin 24.0
Voriconazole 4.0
9.Primary Outcome
Title ELF PK: AUCtau
Hide Description AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: average concentration (ug*hr/mL)
Anidulafungin 21.9
Voriconazole 282
10.Primary Outcome
Title ELF PK: t1/2
Hide Description t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. ELF collected by bronchoscopy and BAL on Day 3.
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects. Data in ELF did not allow calculation of t1/2; not analyzed.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Primary Outcome
Title Alveolar Macrophages (AM): Cmax
Hide Description Cmax = maximum observed plasma concentration; observed directly from the data. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: average concentration (ug/mL)
Anidulafungin 103
Voriconazole 20.5
12.Primary Outcome
Title AM: Tmax
Hide Description Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. AM collected by bronchoscopy and BAL on Day 3.
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: hours
Anidulafungin 24
Voriconazole 4.0
13.Primary Outcome
Title AM: AUCtau
Hide Description AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: average concentration (ug*hr/mL)
Anidulafungin 1430
Voriconazole 178
14.Primary Outcome
Title AM: t1/2
Hide Description t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AM collected by bronchoscopy and BAL on Day 3.
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects. Data in AM did not allow calculation of t1/2; not analyzed.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Primary Outcome
Title Overall Drug Penetration Ratio in ELF
Hide Description ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: average ELF to plasma ratio
Anidulafungin 0.22
Voriconazole 7.14
16.Primary Outcome
Title Concentration Ratio in ELF to Plasma
Hide Description Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.
Time Frame 4, 8, 12, 24 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; summary parameters derived using average data for all subjects. Subjects randomized to a single BAL procedure timepoint; bronchoscopy and BAL done for 5 different subjects at each timepoint.
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ratio
Anidulafungin 4 hours 0.15  (0.02)
Anidulafungin 8 hours 0.15  (0.07)
Anidulafungin 12 hours 0.20  (0.09)
Anidulafungin 24 hours 0.38  (0.14)
Voriconazole 4 hours 9.50  (2.31)
Voriconazole 8 hours 4.93  (2.79)
Voriconazole 12 hours 7.68  (3.41)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anidulafungin and Voriconazole
Hide Arm/Group Description Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
All-Cause Mortality
Anidulafungin and Voriconazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anidulafungin and Voriconazole
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anidulafungin and Voriconazole
Affected / at Risk (%)
Total   15/21 (71.43%) 
Eye disorders   
Photophobia  1  2/21 (9.52%) 
Visual impairment  1  3/21 (14.29%) 
Gastrointestinal disorders   
Nausea  1  1/21 (4.76%) 
Vomiting  1  2/21 (9.52%) 
General disorders   
Influenza like illness  1  4/21 (19.05%) 
Immune system disorders   
Hypersensitivity  1  1/21 (4.76%) 
Investigations   
Liver function test abnormal  1  1/21 (4.76%) 
Nervous system disorders   
Headache  1  6/21 (28.57%) 
Psychiatric disorders   
Hallucination, visual  1  1/21 (4.76%) 
Insomnia  1  1/21 (4.76%) 
Vascular disorders   
Phlebitis  1  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00940017     History of Changes
Other Study ID Numbers: A8851020
First Submitted: July 13, 2009
First Posted: July 15, 2009
Results First Submitted: October 20, 2009
Results First Posted: February 9, 2010
Last Update Posted: February 9, 2010