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An Investigational Study of Hydrocortisone

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ClinicalTrials.gov Identifier: NCT01960530
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Simbec Research
Information provided by (Responsible Party):
Diurnal Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Adrenal Insufficiency
Interventions Drug: Hydrocortisone granules
Drug: Hydrocortisone Tablet
Drug: i.v. Hydrocortisone Injection
Other: Dexamethasone
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5-period Crossover
Hide Arm/Group Description

Study Period 1 (Endogenous Cortisol): No IMP was administered. Subjects were observed over a 24 hour period, during which sleep disruption was minimised, to record their endogenous cortisol production as a baseline figure and to confirm eligibility for the subsequent study periods.

Study Period 2 (Dexamethasone): Subjects were admitted to the unit following a final confirmation of eligibility, prior to administration with Dexamethasone.

Study Periods 3 and 4 (Infacort Granules or Hydrocortisone Tablets): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received both treatments (1 in Period 3, and 1 in Period 4), and were randomised using the PROC PLAN procedure of SAS. Subjects received Dexamethasone 1 hour prior to IMP administration.

Study Period 5 (I.V. Hydrocortisone Injection): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received Dexamethasone 1 hour prior to IMP administration.

Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description All participants received no IMP, dexamethasone (non-IMP), oral infacort, oral hydrocortisone, i.v. hydrocortisone
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Healthy volunteers
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
32.9  (11.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
0
   0.0%
Male
14
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 14 participants
14
1.Primary Outcome
Title Maximum Serum Concentration (Cmax)
Hide Description Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)
Time Frame Hourly from 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol
Arm/Group Title Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Hide Arm/Group Description:

20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Infacort

20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet

20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

i.v. Hydrocortisone Injection

Overall Number of Participants Analyzed 14 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: nmol/L
940.012  (283.773) 896.489  (258.083) 1563.479  (491.267)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infacort®, i.v Hydrocortisone Injection
Comments Evaluation of Cmax
Type of Statistical Test Non-Inferiority or Equivalence
Comments To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.
Method of Estimation Estimation Parameter Geometric LSmean ratio
Estimated Value 60.12
Confidence Interval (2-Sided) 90%
54.69 to 66.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infacort®, Hydrocortisone Tablet
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.
Method of Estimation Estimation Parameter Geometric LSmean ratio
Estimated Value 106.83
Confidence Interval (2-Sided) 90%
96.92 to 117.76
Estimation Comments [Not Specified]
2.Primary Outcome
Title AUC0-t
Hide Description Derived PK for Serum Cortisol: Area under the curve from 0-24 hours
Time Frame Hourly from 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol
Arm/Group Title Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Hide Arm/Group Description:

20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Infacort

20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet

20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

i.v. Hydrocortisone Injection

Overall Number of Participants Analyzed 14 13 14
Geometric Mean (Standard Deviation)
Unit of Measure: nmol*h/L
2543.24  (713.76) 2896.73  (850.31) 2923.46  (971.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infacort®, i.v Hydrocortisone Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 86.99
Confidence Interval (2-Sided) 90%
79.23 to 95.52
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infacort®, Hydrocortisone Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 89.96
Confidence Interval (2-Sided) 90%
81.72 to 99.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Adverse Events (AEs)
Hide Description Number of subjects with adverse events throughout the study.
Time Frame Days 1-2 during each Study Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Hide Arm/Group Description:
No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Dexamethasone

20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Infacort

20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet

20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

i.v. Hydrocortisone Injection

Overall Number of Participants Analyzed 14 14 14 14 14
Measure Type: Number
Unit of Measure: participants
3 3 0 1 2
4.Secondary Outcome
Title Concentrations of Cortisol Binding Protein
Hide Description Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.
Time Frame Blood samples on Day 1 and/or Day 2 of each Study Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Hide Arm/Group Description:
No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Dexamethasone

20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Infacort

20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet

20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

i.v. Hydrocortisone Injection

Overall Number of Participants Analyzed 14 14 14 14 14
Mean (Standard Deviation)
Unit of Measure: ug/mL
22.950  (2.7355) 23.441  (3.0381) 22.386  (2.8753) 21.757  (3.6545) 21.482  (3.2047)
5.Secondary Outcome
Title Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.
Hide Description A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.
Time Frame Blood samples on Day 1 and/or Day 2 of each Study Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Hide Arm/Group Description:
No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Dexamethasone

20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Infacort

20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet

20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

i.v. Hydrocortisone Injection

Overall Number of Participants Analyzed 14 14 14 14 14
Mean (Standard Deviation)
Unit of Measure: uIU/mL
70.529  (17.975) 80.668  (40.801) 77.575  (32.195) 70.650  (34.983) 70.121  (27.140)
6.Secondary Outcome
Title PK and Metabolism of Cortisol
Hide Description Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.
Time Frame Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Hide Arm/Group Description:
No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Dexamethasone

20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Infacort

20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet

20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

i.v. Hydrocortisone Injection

Overall Number of Participants Analyzed 14 14 14 14 14
Mean (Standard Deviation)
Unit of Measure: nmol/L
447.355  (77.005) 19.349  (9.567) 963.134  (283.376) 893.077  (259.730) 1580.337  (492.285)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Hide Arm/Group Description No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Dexamethasone

20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Infacort

20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet

20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

i.v. Hydrocortisone Injection

All-Cause Mortality
Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Endogenous Cortisol Dexamethasone Infacort® Hydrocortisone Tablet i.v Hydrocortisone Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/14 (21.43%)      3/14 (21.43%)      0/14 (0.00%)      1/14 (7.14%)      2/14 (14.29%)    
Eye disorders           
Vision blurred * 1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0
Gastrointestinal disorders           
Dyspepsia * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
General disorders           
Fatigue * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Pyrexia * 1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0
Infections and infestations           
Nasopharyngitis * 1  1/14 (7.14%)  1 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0
Nervous system disorders           
Headache * 1  1/14 (7.14%)  1 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0
Psychiatric disorders           
Mood swings * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
*
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.
The investigator must obtain written consent from the Sponsor prior to any publication of results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr John Porter
Organization: Diurnal Limited
Phone: 02920 682069
EMail: info@diurnal.com
Layout table for additonal information
Responsible Party: Diurnal Limited
ClinicalTrials.gov Identifier: NCT01960530     History of Changes
Other Study ID Numbers: Infacort 002
First Submitted: October 6, 2013
First Posted: October 10, 2013
Results First Submitted: April 14, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017