Trial Outcomes & Findings for Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function (NCT NCT01732263)
NCT ID: NCT01732263
Last Updated: 2021-07-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Over 96 hours post-dose
Results posted on
2021-07-19
Participant Flow
One subject withdrew from study prior to randomization (n = 43).
Participant milestones
| Measure |
Hepatic Impairment
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).
|
Matched Healthy Subjects
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 Study
STARTED
|
23
|
20
|
|
Overall Study
COMPLETED
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
Baseline characteristics by cohort
| Measure |
Hepatic Impairment
n=23 Participants
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).
|
Matched Healthy Subjects
n=20 Participants
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
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 Years
STANDARD_DEVIATION 5.13 • n=5 Participants
|
55.1 Years
STANDARD_DEVIATION 5.51 • n=7 Participants
|
55.7 Years
STANDARD_DEVIATION 5.28 • n=5 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg
n=8 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg
n=5 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg
n=3 Participants
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).
|
SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg
n=7 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 45 mg/kg
n=10 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 50 mg/kg
n=10 Participants
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).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
|
254327.7 ng*h/ml
Standard Deviation 57645.3
|
443053.5 ng*h/ml
Standard Deviation 157352.1
|
288579.6 ng*h/ml
Standard Deviation 149123.5
|
410414.3 ng*h/ml
Standard Deviation 111201.8
|
209989.8 ng*h/ml
Standard Deviation 83155.2
|
310281.3 ng*h/ml
Standard Deviation 112004.9
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg
n=8 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg
n=5 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg
n=3 Participants
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).
|
SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg
n=7 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 45 mg/kg
n=10 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 50 mg/kg
n=10 Participants
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).
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SSP-004184
|
98887.5 ng/ml
Standard Deviation 29689.1
|
121460.0 ng/ml
Standard Deviation 28777.7
|
109166.7 ng/ml
Standard Deviation 52920.5
|
123985.0 ng/ml
Standard Deviation 34807.1
|
83350.0 ng/ml
Standard Deviation 28538.1
|
108890.0 ng/ml
Standard Deviation 41016.6
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: 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.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Outcome measures
| Measure |
SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg
n=8 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg
n=5 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg
n=3 Participants
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).
|
SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg
n=7 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 45 mg/kg
n=10 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 50 mg/kg
n=10 Participants
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).
|
|---|---|---|---|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) for SSP-004184
|
1.3 hours
Interval 1.0 to 1.5
|
1.5 hours
Interval 1.0 to 2.5
|
1.5 hours
Interval 1.0 to 1.5
|
1.5 hours
Interval 1.0 to 2.5
|
1.0 hours
Interval 1.0 to 1.5
|
1.0 hours
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: 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.
The time it takes for the blood plasma concentration of a substance to halve.
Outcome measures
| Measure |
SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg
n=8 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg
n=5 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg
n=3 Participants
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).
|
SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg
n=7 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 45 mg/kg
n=10 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 50 mg/kg
n=10 Participants
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).
|
|---|---|---|---|---|---|---|
|
Plasma Half-Life (T 1/2) of SSP-004184
|
21.91 hours
Standard Deviation 17.54
|
11.37 hours
Standard Deviation 6.47
|
6.93 hours
Standard Deviation 0.94
|
6.79 hours
Standard Deviation 3.97
|
12.51 hours
Standard Deviation 4.51
|
16.19 hours
Standard Deviation 8.62
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: 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.
The rate at which a drug is removed from the body.
Outcome measures
| Measure |
SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg
n=8 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg
n=5 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg
n=3 Participants
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).
|
SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg
n=7 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 45 mg/kg
n=10 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 50 mg/kg
n=10 Participants
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 Body Clearance (CL/F) of SSP-004184
|
0.204 L/h/kg
Standard Deviation 0.042
|
0.110 L/h/kg
Standard Deviation 0.035
|
0.198 L/h/kg
Standard Deviation 0.099
|
0.119 L/h/kg
Standard Deviation 0.047
|
0.246 L/h/kg
Standard Deviation 0.097
|
0.182 L/h/kg
Standard Deviation 0.072
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: 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.
The distribution of a medication between plasma and the rest of the body.
Outcome measures
| Measure |
SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg
n=8 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg
n=5 Participants
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).
|
SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg
n=3 Participants
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).
|
SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg
n=7 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 45 mg/kg
n=10 Participants
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).
|
SSP-004184 (Matched Healthy Subjects) 50 mg/kg
n=10 Participants
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).
|
|---|---|---|---|---|---|---|
|
Volume of Distribution (Vz/F) of SSP-004184
|
6.344 L/kg
Standard Deviation 5.276
|
1.796 L/kg
Standard Deviation 1.210
|
2.043 L/kg
Standard Deviation 1.259
|
1.370 L/kg
Standard Deviation 1.539
|
4.103 L/kg
Standard Deviation 1.420
|
4.086 L/kg
Standard Deviation 2.237
|
Adverse Events
Hepatic Impairment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Matched Healthy Subjects
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hepatic Impairment
n=23 participants at risk
|
Matched Healthy Subjects
n=20 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/23
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2
|
20.0%
4/20 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Chromaturia
|
43.5%
10/23 • Number of events 10
|
85.0%
17/20 • Number of events 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER