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A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)

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ClinicalTrials.gov Identifier: NCT00945321
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : June 30, 2010
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chemotherapy-Induced Nausea and Vomiting
Interventions Drug: aprepitant 165 mg
Drug: Comparator: aprepitant 185 mg
Drug: Comparator: fosaprepitant 150 mg
Drug: Comparator: aprepitant with food
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A/B/C/D B/C/A/D C/A/B/D A/C/B/E B/A/C/E C/B/A/E
Hide Arm/Group Description

Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.

(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)

Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.

(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)

Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.

(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)

Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.

(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)

Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.

(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)

Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.

(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)

Period Title: Period 1
Started 7 7 7 7 7 7
Completed 7 7 7 7 6 7
Not Completed 0 0 0 0 1 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0
Period Title: Period 2
Started 7 7 7 7 6 7
Completed 7 7 7 7 6 7
Not Completed 0 0 0 0 0 0
Period Title: Period 3
Started 7 7 7 7 6 7
Completed 7 7 7 7 6 7
Not Completed 0 0 0 0 0 0
Period Title: Period 4
Started 7 7 7 7 6 7
Completed 7 7 7 7 6 6
Not Completed 0 0 0 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             0             0             0             1
Arm/Group Title All Participants
Hide Arm/Group Description All randomized patients.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
27.8
(18 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
10
  23.8%
Male
32
  76.2%
Height  
Mean (Full Range)
Unit of measure:  Centimeters
Number Analyzed 42 participants
172.9
(151.1 to 190.5)
Weight  
Mean (Full Range)
Unit of measure:  Kilograms
Number Analyzed 42 participants
74.2
(44.9 to 91.2)
1.Primary Outcome
Title Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg
Hide Description [Not Specified]
Time Frame Through 72 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.
Arm/Group Title 165 mg Aprepitant (Fasted State) 185 mg Aprepitant (Fasted State) 150 mg Fosaprepitant Dimeglumine (Fasted State) 165 mg Aprepitant (Light) 165 mg Aprepitant (High-Fat) 185 mg Aprepitant (Light) 185 mg Aprepitant (High-Fat)
Hide Arm/Group Description:
165 mg aprepitant Final Market Composition capsule in the fasted state
185 mg aprepitant Final Market Composition capsule in the fasted state
150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state

165 mg aprepitant Final Market Composition capsule in the fed state.

(The subjects (9) in this treatment group received a standard light breakfast.)

165 mg aprepitant Final Market Composition capsule in the fed state.

(The (12) subjects in this treatment group received a standard high-fat breakfast.)

185 mg aprepitant Final Market Composition capsule in the fed state.

(The subjects (9) in this treatment group received a standard light breakfast.)

185 mg aprepitant Final Market Composition capsule in the fed state.

(The (12) subjects in this treatment group received a standard high-fat breakfast.)

Overall Number of Participants Analyzed 41 41 41 9 12 9 11
Mean (Standard Deviation)
Unit of Measure: ng•hr/mL
34589  (39.7) 39053  (37.5) 37375  (39.5) 37795  (48.4) 50172  (22.0) 51146  (27.2) 60578  (57.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 165 mg Aprepitant (Fasted State), 150 mg Fosaprepitant Dimeglumine (Fasted State)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence Bounds of (0.80, 1.25).
Statistical Test of Hypothesis P-Value 0.001
Comments Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels.
Method two one-sided tests
Comments The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR>0.80 and GMR≥1.25 vs. GMR<1.25).
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.84 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 185 mg Aprepitant (Fasted State), 150 mg Fosaprepitant Dimeglumine (Fasted State)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence Bounds of (0.80, 1.25).
Statistical Test of Hypothesis P-Value <0.001
Comments Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels
Method two one-sided tests
Comments The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR>0.80 and GMR≥1.25 vs. GMR<1.25).
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.96 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 165 mg Aprepitant (Fasted State), 165 mg Aprepitant (High-Fat)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.47
Confidence Interval (2-Sided) 90%
1.23 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 165 mg Aprepitant (Fasted State), 165 mg Aprepitant (Light)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
0.88 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 185 mg Aprepitant (Fasted State), 185 mg Aprepitant (High-Fat)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.22
Confidence Interval (2-Sided) 90%
1.01 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 185 mg Aprepitant (Fasted State), 185 mg Aprepitant (Light)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.43
Confidence Interval (2-Sided) 90%
1.16 to 1.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.
Hide Description [Not Specified]
Time Frame Through 72 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.
Arm/Group Title 165 mg Aprepitant (Fasted State) 185 mg Aprepitant (Fasted State) 165 mg Aprepitant (Light) 165 mg Aprepitant (High-Fat) 185 mg Aprepitant (Light) 185 mg Aprepitant (High-Fat)
Hide Arm/Group Description:
165 mg aprepitant Final Market Composition capsule in the fasted state
185 mg aprepitant Final Market Composition capsule in the fasted state

165 mg aprepitant Final Market Composition capsule in the fed state.

(The subjects (9) in this treatment group received a standard light breakfast.)

165 mg aprepitant Final Market Composition capsule in the fed state.

(The (12) subjects in this treatment group received a standard high-fat breakfast.)

185 mg aprepitant Final Market Composition capsule in the fed state.

(The subjects (9) in this treatment group received a standard light breakfast.)

185 mg aprepitant Final Market Composition capsule in the fed state.

(The (12) subjects in this treatment group received a standard high-fat breakfast.)

Overall Number of Participants Analyzed 41 41 9 12 9 11
Mean (Standard Error)
Unit of Measure: ng/mL
1738  (30.8) 1636  (31.2) 1870  (33.3) 2362  (38.5) 2116  (14.8) 1995  (35.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 165 mg Aprepitant (Fasted State), 165 mg Aprepitant (High-Fat)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.33
Confidence Interval (2-Sided) 90%
1.13 to 1.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 165 mg Aprepitant (Fasted State), 165 mg Aprepitant (Light)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.86 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 185 mg Aprepitant (Fasted State), 185 mg Aprepitant (High-Fat)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.14
Confidence Interval (2-Sided) 90%
0.96 to 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 185 mg Aprepitant (Fasted State), 185 mg Aprepitant (Light)
Comments The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.40
Confidence Interval (2-Sided) 90%
1.16 to 1.68
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 165 mg Aprepitant 185 mg Aprepitant 150 mg Fosaprepitant Dimeglumine 165 mg Aprepitant (Fed State) 185 mg Aprepitant (Fed State)
Hide Arm/Group Description 165 mg aprepitant Final Market Composition capsule in the fasted state 185 mg aprepitant Final Market Composition capsule in the fasted state 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state

165 mg aprepitant Final Market Composition capsule in the fed

state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the

subjects (9) in this treatment group received a standard light breakfast)

185 mg aprepitant Final Market Composition capsule in the fed state.

(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)

All-Cause Mortality
165 mg Aprepitant 185 mg Aprepitant 150 mg Fosaprepitant Dimeglumine 165 mg Aprepitant (Fed State) 185 mg Aprepitant (Fed State)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
165 mg Aprepitant 185 mg Aprepitant 150 mg Fosaprepitant Dimeglumine 165 mg Aprepitant (Fed State) 185 mg Aprepitant (Fed State)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   1/42 (2.38%)   0/41 (0.00%)   0/21 (0.00%)   0/20 (0.00%) 
Injury, poisoning and procedural complications           
Accidental Overdose * 1 [1]  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[1]
Accidental Overdose reported for 1 subject who inadvertently received 5 capsules of 185 mg aprepitant (925 mg) instead of the protocol prescribed 1 capsule. The subject was discontinued from the study.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
165 mg Aprepitant 185 mg Aprepitant 150 mg Fosaprepitant Dimeglumine 165 mg Aprepitant (Fed State) 185 mg Aprepitant (Fed State)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/41 (29.27%)   13/42 (30.95%)   15/41 (36.59%)   6/21 (28.57%)   3/20 (15.00%) 
Eye disorders           
Eye Movement Disorder * 1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain * 1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/21 (0.00%)  0/20 (0.00%) 
Abdominal Pain Upper * 1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  1/21 (4.76%)  0/20 (0.00%) 
Diarrhoea * 1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/21 (4.76%)  0/20 (0.00%) 
Nausea * 1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
Vomiting * 1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
General disorders           
Chest Discomfort * 1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/21 (0.00%)  0/20 (0.00%) 
Chest Pain * 1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/21 (4.76%)  0/20 (0.00%) 
Infusion Site Erythema * 1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/21 (0.00%)  0/20 (0.00%) 
Infusion Site Induration * 1  0/41 (0.00%)  1/42 (2.38%)  2/41 (4.88%)  0/21 (0.00%)  0/20 (0.00%) 
Infusion Site Mass * 1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/21 (4.76%)  0/20 (0.00%) 
Puncture Site Indurations * 1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/21 (4.76%)  0/20 (0.00%) 
Infections and infestations           
Nasopharyngitis * 1  1/41 (2.44%)  2/42 (4.76%)  0/41 (0.00%)  1/21 (4.76%)  0/20 (0.00%) 
Injury, poisoning and procedural complications           
Procedureal Dizziness * 1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders           
Myalgia * 1  1/41 (2.44%)  0/42 (0.00%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
Nervous system disorders           
Dizziness * 1  3/41 (7.32%)  3/42 (7.14%)  1/41 (2.44%)  0/21 (0.00%)  0/20 (0.00%) 
Headache * 1  9/41 (21.95%)  6/42 (14.29%)  6/41 (14.63%)  1/21 (4.76%)  1/20 (5.00%) 
Somnolence * 1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  2/21 (9.52%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders           
Nasal Congestion * 1  2/41 (4.88%)  0/42 (0.00%)  2/41 (4.88%)  0/21 (0.00%)  0/20 (0.00%) 
Oropharyngial Pain * 1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/21 (0.00%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders           
Ecchymosis * 1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
Hyperhidrosis * 1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/21 (0.00%)  0/20 (0.00%) 
Vascular disorders           
Vein Pain * 1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/21 (0.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00945321    
Other Study ID Numbers: 0869-165
2009_624
MK-0869-165
First Submitted: July 23, 2009
First Posted: July 24, 2009
Results First Submitted: April 22, 2010
Results First Posted: June 30, 2010
Last Update Posted: January 28, 2015