Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 581 for:    bilirubin AND liver function

Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function

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: NCT01732263
Recruitment Status : Completed
First Posted : November 22, 2012
Results First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatic Impairment
Healthy
Intervention Drug: SSP-004184
Enrollment 44
Recruitment Details  
Pre-assignment Details One subject withdrew from study prior to randomization (n = 43).
Arm/Group Title Hepatic Impairment Matched Healthy Subjects
Hide Arm/Group Description All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted). All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
Period Title: Overall Study
Started 23 20
Completed 23 20
Not Completed 0 0
Arm/Group Title Hepatic Impairment Matched Healthy Subjects Total
Hide Arm/Group Description All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted). All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted). Total of all reporting groups
Overall Number of Baseline Participants 23 20 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 20 participants 43 participants
56.3  (5.13) 55.1  (5.51) 55.7  (5.28)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 43 participants
>=65 years 1 0 1
Between 18 and 65 years 22 20 42
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 43 participants
Female
4
  17.4%
4
  20.0%
8
  18.6%
Male
19
  82.6%
16
  80.0%
35
  81.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
UNITED STATES Number Analyzed 23 participants 20 participants 43 participants
23 20 43
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 50 mg/kg
Hide Arm/Group Description:

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
Overall Number of Participants Analyzed 8 5 3 7 10 10
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
254327.7  (57645.3) 443053.5  (157352.1) 288579.6  (149123.5) 410414.3  (111201.8) 209989.8  (83155.2) 310281.3  (112004.9)
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of SSP-004184
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 50 mg/kg
Hide Arm/Group Description:

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
Overall Number of Participants Analyzed 8 5 3 7 10 10
Mean (Standard Deviation)
Unit of Measure: ng/ml
98887.5  (29689.1) 121460.0  (28777.7) 109166.7  (52920.5) 123985.0  (34807.1) 83350.0  (28538.1) 108890.0  (41016.6)
3.Primary Outcome
Title Time of Maximum Plasma Concentration (Tmax) for SSP-004184
Hide Description Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 50 mg/kg
Hide Arm/Group Description:

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
Overall Number of Participants Analyzed 8 5 3 7 10 10
Median (Full Range)
Unit of Measure: hours
1.3
(1.0 to 1.5)
1.5
(1.0 to 2.5)
1.5
(1.0 to 1.5)
1.5
(1.0 to 2.5)
1.0
(1.0 to 1.5)
1.0
(1.0 to 2.0)
4.Primary Outcome
Title Plasma Half-Life (T 1/2) of SSP-004184
Hide Description The time it takes for the blood plasma concentration of a substance to halve.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 50 mg/kg
Hide Arm/Group Description:

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
Overall Number of Participants Analyzed 8 5 3 7 10 10
Mean (Standard Deviation)
Unit of Measure: hours
21.91  (17.54) 11.37  (6.47) 6.93  (0.94) 6.79  (3.97) 12.51  (4.51) 16.19  (8.62)
5.Primary Outcome
Title Total Body Clearance (CL/F) of SSP-004184
Hide Description The rate at which a drug is removed from the body.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 50 mg/kg
Hide Arm/Group Description:

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
Overall Number of Participants Analyzed 8 5 3 7 10 10
Mean (Standard Deviation)
Unit of Measure: L/h/kg
0.204  (0.042) 0.110  (0.035) 0.198  (0.099) 0.119  (0.047) 0.246  (0.097) 0.182  (0.072)
6.Primary Outcome
Title Volume of Distribution (Vz/F) of SSP-004184
Hide Description The distribution of a medication between plasma and the rest of the body.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 45 mg/kg SSP-004184 (Matched Healthy Subjects) 50 mg/kg
Hide Arm/Group Description:

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
Overall Number of Participants Analyzed 8 5 3 7 10 10
Mean (Standard Deviation)
Unit of Measure: L/kg
6.344  (5.276) 1.796  (1.210) 2.043  (1.259) 1.370  (1.539) 4.103  (1.420) 4.086  (2.237)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hepatic Impairment Matched Healthy Subjects
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Hepatic Impairment Matched Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hepatic Impairment Matched Healthy Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hepatic Impairment Matched Healthy Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/23 (52.17%)      17/20 (85.00%)    
Gastrointestinal disorders     
Constipation  1/23 (4.35%)  1 1/20 (5.00%)  1
General disorders     
Fatigue  0/23 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations     
Nasopharyngitis  0/23 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
Headache  2/23 (8.70%)  2 4/20 (20.00%)  4
Psychiatric disorders     
Anxiety  0/23 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders     
Chromaturia  10/23 (43.48%)  10 17/20 (85.00%)  17
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01732263     History of Changes
Other Study ID Numbers: SPD602-105
First Submitted: November 19, 2012
First Posted: November 22, 2012
Results First Submitted: April 16, 2014
Results First Posted: May 15, 2014
Last Update Posted: May 15, 2014