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A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

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ClinicalTrials.gov Identifier: NCT00638989
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Asthma
Healthy
Interventions Biological: CAT-354 150 mg (intravenous)
Biological: CAT-354 150 mg (subcutaneous)
Biological: CAT-354 300 mg (subcutaneous)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Period Title: Overall Study
Started 10 10 10
Completed 10 10 9
Not Completed 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             1
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous) Total
Hide Arm/Group Description A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. A single dose of CAT-354 300 mg injection subcutaneously on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 30
Hide Baseline Analysis Population Description
Analysis population included all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 30 participants
30.4  (8.3) 39.3  (8.6) 27.8  (10.4) 32.5  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
10
 100.0%
30
 100.0%
1.Primary Outcome
Title Absolute Bioavailability of CAT-354 After Subcutaneous Dose
Hide Description Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC [0 - infinity]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate maximum observed serum concentration (Cmax).
Arm/Group Title CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10
Geometric Mean (90% Confidence Interval)
Unit of Measure: percent bioavailability
62.1
(48.5 to 79.6)
60.1
(46.9 to 77.1)
2.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Day 0 to 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Measure Type: Number
Unit of Measure: participants
TEAEs 5 5 4
TESAEs 0 0 0
3.Secondary Outcome
Title Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit
Hide Description [Not Specified]
Time Frame Day 0 and Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0
4.Secondary Outcome
Title Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])
Hide Description AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: (microgram*day)/milliliter (mcg*day/mL)
903  (291) 548  (143) 1080  (315)
5.Secondary Outcome
Title Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])
Hide Description [Not Specified]
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: mcg*day/mL
765  (220) 467  (122) 881  (287)
6.Secondary Outcome
Title Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)
Hide Description AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC [0 - infinity]) was normalized by CAT-354 dose.
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: ([mcg*day]/mL)/mg
6.02  (1.94) 3.66  (0.953) 3.59  (1.05)
7.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: microgram/milliliter (mcg/mL)
58.3  (14.4) 17.1  (5.91) 36.6  (13.1)
8.Secondary Outcome
Title Dose Normalized Maximum Observed Concentration (Cmax/Dose)
Hide Description [Not Specified]
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: (mcg/mL)/mg
0.389  (0.096) 0.114  (0.039) 0.122  (0.044)
9.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Median (Full Range)
Unit of Measure: days
0.063
(0.042 to 1.02)
5
(3 to 9)
5
(3 to 9)
10.Secondary Outcome
Title Terminal Phase Elimination Half Life (t1/2)
Hide Description Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: days
21.4  (2.46) 19.2  (3.1) 19.4  (3.59)
11.Secondary Outcome
Title Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).
Time Frame Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description:
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mL/day
292  (82.3) 307  (109)
12.Secondary Outcome
Title Apparent Systemic Clearance (CL/F) After Intravenous Dose
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mL/day
188  (84.0)
13.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) After Intravenous Infusion
Hide Description Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM[Infinity] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity).
Time Frame Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Arm/Group Title CAT-354 150 mg (Intravenous)
Hide Arm/Group Description:
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mL
4960  (1440)
Time Frame Day 0 to 56
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Hide Arm/Group Description A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
All-Cause Mortality
CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CAT-354 150 mg (Intravenous) CAT-354 150 mg (Subcutaneous) CAT-354 300 mg (Subcutaneous)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      5/10 (50.00%)      4/10 (40.00%)    
Eye disorders       
Eye pruritus  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
General disorders       
Feeling cold  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Feeling hot  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Injury, poisoning and procedural complications       
Post-traumatic pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Procedural pain  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Sunburn  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  2
Musculoskeletal and connective tissue disorders       
Back pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Joint swelling  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Pain in extremity  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Melanocytic naevus  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders       
Dizziness  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Headache  1  4/10 (40.00%)  4 4/10 (40.00%)  7 1/10 (10.00%)  3
Sinus headache  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Somnolence  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Reproductive system and breast disorders       
Breast mass  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Breast tenderness  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Epistaxis  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Nasal congestion  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Paranasal sinus hype  1  0/10 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0
Pharyngolaryngeal pa  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Rhinorrhoea  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Sinus congestion  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Sneezing  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title: Meena Jain, MB BChir/Associate Medical Director
Organization: MedImmune, LLC
Phone: 301-398-0000
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00638989     History of Changes
Other Study ID Numbers: CAT-354-0703
First Submitted: March 12, 2008
First Posted: March 19, 2008
Results First Submitted: March 22, 2017
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017