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The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSP-004184 (Child-Pugh A Liver Impaired) | Experimental | 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. |
|
| SSP-004184 (Child-Pugh B Liver Impaired) | Experimental |
| |
| SSP-004184 (Child-Pugh C Liver Impaired) | Experimental |
| |
| SSP-004184 (Matched Healthy Subjects) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSP-004184 | Drug | All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184 | 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. | Over 96 hours post-dose |
| Maximum Plasma Concentration (Cmax) of SSP-004184 | 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. | Over 96 hours post-dose |
| Time of Maximum Plasma Concentration (Tmax) for SSP-004184 | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | Over 96 hours post-dose |
| Plasma Half-Life (T 1/2) of SSP-004184 | The time it takes for the blood plasma concentration of a substance to halve. | Over 96 hours post-dose |
| Total Body Clearance (CL/F) of SSP-004184 | The rate at which a drug is removed from the body. | Over 96 hours post-dose |
| Volume of Distribution (Vz/F) of SSP-004184 | The distribution of a medication between plasma and the rest of the body. | Over 96 hours post-dose |
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Inclusion Criteria:
Subjects who do not have hepatic impairment (healthy subjects)
Subjects with hepatic impairment
Exclusion Criteria
Subjects who do not have hepatic impairment (healthy subjects)
Subjects with hepatic impairment
All subjects
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center (OCRC) |
One subject withdrew from study prior to randomization (n = 43).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Matched Healthy Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184 | 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. | 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. | Posted | Mean | Standard Deviation | ng*h/ml | Over 96 hours post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hepatic Impairment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| C572777 | 4,5-dihydro-2-(2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl)-4-methyl-4-thiazolecarboxylic acid |
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|
| Orlando |
| Florida |
| 32809 |
| United States |
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).
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg | 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). |
| OG002 | SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg | 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). |
| OG003 | SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg | 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). |
| OG004 | SSP-004184 (Matched Healthy Subjects) 45 mg/kg | 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). |
| OG005 | SSP-004184 (Matched Healthy Subjects) 50 mg/kg | 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). |
|
|
| Primary | Maximum Plasma Concentration (Cmax) of SSP-004184 | 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. | 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. | Posted | Mean | Standard Deviation | ng/ml | Over 96 hours post-dose |
|
|
|
| Primary | Time of Maximum Plasma Concentration (Tmax) for SSP-004184 | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | 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. | Posted | Median | Full Range | hours | Over 96 hours post-dose |
|
|
|
| Primary | Plasma Half-Life (T 1/2) of SSP-004184 | The time it takes for the blood plasma concentration of a substance to halve. | 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. | Posted | Mean | Standard Deviation | hours | Over 96 hours post-dose |
|
|
|
| Primary | Total Body Clearance (CL/F) of SSP-004184 | The rate at which a drug is removed from the body. | 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. | Posted | Mean | Standard Deviation | L/h/kg | Over 96 hours post-dose |
|
|
|
| Primary | Volume of Distribution (Vz/F) of SSP-004184 | The distribution of a medication between plasma and the rest of the body. | 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. | Posted | Mean | Standard Deviation | L/kg | Over 96 hours post-dose |
|
|
|
| 0 |
| 23 |
| 12 |
| 23 |
| EG001 | Matched Healthy Subjects | 0 | 20 | 17 | 20 |
| Fatigue | General disorders |
|
| Nasopharyngitis | Infections and infestations |
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| Headache | Nervous system disorders |
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| Anxiety | Psychiatric disorders |
|
| Chromaturia | Renal and urinary disorders |
|
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.