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A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277274
Recruitment Status : Completed
First Posted : September 11, 2017
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Hepatic Impairment
Healthy Volunteers
Intervention Drug: TAK-954
Enrollment 25
Recruitment Details Participants took part in the study at 2 investigative sites in Czech Republic and Slovakia from 09 November 2017 to 10 September 2018.
Pre-assignment Details Participants with normal hepatic function and hepatic impairment were enrolled in 1 of the groups:B(moderate), C(severe) or D(healthy) to receive TAK-954 0.2mg. Based on available safety and PK data from Group B, participants were enrolled in reduced study design and were not enrolled in GroupA(mild). Groups A-D are equal to Groups 1-4 in protocol.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1. TAK-954 0.2 mg, infusion, intravenously, once on Day 1. TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Period Title: Overall Study
Started 8 10 7
Completed 8 10 7
Not Completed 0 0 0
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg Total
Hide Arm/Group Description TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1. TAK-954 0.2 mg, infusion, intravenously, once on Day 1. TAK-954 0.2 mg, infusion, intravenously, once on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 8 10 7 25
Hide Baseline Analysis Population Description
The safety set consisted of all participants who were enrolled and received the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 10 participants 7 participants 25 participants
58.5  (9.46) 55.6  (12.25) 57.9  (12.88) 57.2  (11.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 7 participants 25 participants
Female
3
  37.5%
4
  40.0%
1
  14.3%
8
  32.0%
Male
5
  62.5%
6
  60.0%
6
  85.7%
17
  68.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 7 participants 25 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
10
 100.0%
7
 100.0%
25
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 7 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
8
 100.0%
10
 100.0%
7
 100.0%
25
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 7 participants 25 participants
Czech Republic
3
  37.5%
3
  30.0%
2
  28.6%
8
  32.0%
Slovakia
5
  62.5%
7
  70.0%
5
  71.4%
17
  68.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 8 participants 10 participants 7 participants 25 participants
89.95  (17.098) 86.77  (19.823) 87.19  (21.331) 87.90  (18.667)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 8 participants 10 participants 7 participants 25 participants
31.1  (3.18) 30.4  (5.02) 27.9  (6.18) 29.9  (4.87)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 8 participants 10 participants 7 participants 25 participants
169.8  (11.30) 168.0  (10.47) 176.1  (6.28) 170.8  (10.01)
1.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
Hide Description [Not Specified]
Time Frame Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
TAK-954 (Total)
2.629
(19.1%)
2.440
(25.3%)
1.893
(35.4%)
TAK-954 (Free)
0.1381
(15.6%)
0.1799
(24.4%)
0.1778
(23.1%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.579
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Total and Free)
Hide Description [Not Specified]
Time Frame Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
TAK-954 (Total)
28.57
(19.2%)
23.57
(26.2%)
20.19
(32.7%)
TAK-954 (Free)
1.501
(12.0%)
1.737
(23.0%)
1.898
(19.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-954 (Total and Free)
Hide Description [Not Specified]
Time Frame Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
TAK-954 (Total)
31.30
(20.1%)
25.44
(27.1%)
22.60
(34.3%)
TAK-954 (Free)
1.643
(13.8%)
1.875
(24.0%)
2.122
(21.8%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.201
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Healthy Participants: TAK-954 0.2 mg, Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Clinically Significant Physical Examination Findings
Hide Description [Not Specified]
Time Frame Up to 14 days after the last dose of study drug (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set consisted of all participants who were enrolled and received the study drug.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 10 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Markedly Abnormal Electrocardiograms (ECGs)
Hide Description [Not Specified]
Time Frame Up to 14 days after the last dose of study drug (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set consisted of all participants who were enrolled and received the study drug.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 10 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2
  28.6%
6.Secondary Outcome
Title Number of Participants With Markedly Abnormal Values of Vital Signs
Hide Description [Not Specified]
Time Frame Up to 14 days after the last dose of study drug (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set consisted of all participants who were enrolled and received the study drug.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 10 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  10.0%
1
  14.3%
7.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Hide Description [Not Specified]
Time Frame Up to 14 days after the last dose of study drug (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set consisted of all participants who were enrolled and received the study drug.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 10 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Hide Description [Not Specified]
Time Frame Baseline up to 30 days after last dose of study drug (Day 31)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set consisted of all participants who were enrolled and received the study drug.
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description:
TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
Overall Number of Participants Analyzed 8 10 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
3
  30.0%
1
  14.3%
Time Frame TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after the last dose of study drug
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Hide Arm/Group Description TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1. TAK-954 0.2 mg, infusion, intravenously, once on Day 1. TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
All-Cause Mortality
Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/10 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/10 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Participants: TAK-954 0.2 mg Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg Group C, Severe Hepatic Impairment: TAK-954 0.2 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/8 (25.00%)      3/10 (30.00%)      1/7 (14.29%)    
Gastrointestinal disorders       
Diarrhoea  1  1/8 (12.50%)  1 2/10 (20.00%)  2 1/7 (14.29%)  1
Flatulence  1  0/8 (0.00%)  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Nervous system disorders       
Headache  1  1/8 (12.50%)  1 0/10 (0.00%)  0 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03277274    
Other Study ID Numbers: TAK-954-1006
2017-000714-37 ( EudraCT Number )
U1111-1196-9190 ( Registry Identifier: WHO )
First Submitted: September 7, 2017
First Posted: September 11, 2017
Results First Submitted: August 28, 2019
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019