Back to resultsStudy of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
Primary Purpose
Hepatic Impairment, Healthy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SSP-004184
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years inclusive at the time of consent.
- Willingness to comply with any applicable contraceptive requirements of the protocol and is:
- Male, or
- Non pregnant, non lactating female
- Females must be at least 90 days post partum or nulliparous.
Subjects who do not have hepatic impairment (healthy subjects)
- Normal renal function.
Subjects with hepatic impairment
- Subjects must provide a letter of evaluation from a hepatologist or copy of supporting documents confirming the subject's hepatic impairment (a liver biopsy is preferable but not mandatory).
- Hepatic impairment should be primary and must not be a complication of an underlying primary systemic disease (eg, patients with metastatic cancer and cancer cachexia)
- Documented chronic stable liver impairment
Exclusion Criteria
Subjects who do not have hepatic impairment (healthy subjects)
- A positive HIV antibody screen, Hepatitis B surface antigen, or Hepatitis C virus antibody screen.
Subjects with hepatic impairment
- Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by an infection or drug toxicity.
- Presence of surgically created or transjugular intrahepatic portal systemic shunts.
- A positive HIV antibody screen.
- Renal insufficiency.
All subjects
- Subject has a history of thyroid disorder.
- History of nephrotic syndrome.
- History of alcohol or other substance abuse within the last year.
- A positive screen for alcohol or drugs of abuse.
- Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit = 1 beer [12 oz/355 mL] = 1 wine [5 oz/150 mL] = 1 liquor [1.5 oz/40 mL] = 0.75 oz/20 mL alcohol.)
- Caffeine consumption: For healthy subjects: Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6 oz/180 mL cup of coffee, two 12 oz/355 mL (ie, 24 oz/710 mL cola) cans of cola, one 12 oz/355 mL cup of tea, three 1 oz/28 g chocolate bars (ie, 3 oz/85 g chocolate). Decaffeinated coffee, tea, or cola are not considered to contain caffeine.)
- Donation of blood or blood products within 60 days.
- Substantial changes in eating habits within 30 days.
Sites / Locations
- Clinical Pharmacology of Miami
- Orlando Clinical Research Center (OCRC)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
SSP-004184 (Child-Pugh A Liver Impaired)
SSP-004184 (Child-Pugh B Liver Impaired)
SSP-004184 (Child-Pugh C Liver Impaired)
SSP-004184 (Matched Healthy Subjects)
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Plasma Half-Life (T 1/2) of SSP-004184
The time it takes for the blood plasma concentration of a substance to halve.
Total Body Clearance (CL/F) of SSP-004184
The rate at which a drug is removed from the body.
Volume of Distribution (Vz/F) of SSP-004184
The distribution of a medication between plasma and the rest of the body.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01732263
Brief Title
Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
Official Title
A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (SPD602) in Subjects With Hepatic Impairment Compared to Matched Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2012 (Actual)
Primary Completion Date
April 1, 2013 (Actual)
Study Completion Date
April 1, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSP-004184 (Child-Pugh A Liver Impaired)
Arm Type
Experimental
Arm 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.
Arm Title
SSP-004184 (Child-Pugh B Liver Impaired)
Arm Type
Experimental
Arm Title
SSP-004184 (Child-Pugh C Liver Impaired)
Arm Type
Experimental
Arm Title
SSP-004184 (Matched Healthy Subjects)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SSP-004184
Other Intervention Name(s)
SPD602, FBS0701
Intervention Description
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
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
Title
Maximum Plasma Concentration (Cmax) of SSP-004184
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
Title
Time of Maximum Plasma Concentration (Tmax) for SSP-004184
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
Title
Plasma Half-Life (T 1/2) of SSP-004184
Description
The time it takes for the blood plasma concentration of a substance to halve.
Time Frame
Over 96 hours post-dose
Title
Total Body Clearance (CL/F) of SSP-004184
Description
The rate at which a drug is removed from the body.
Time Frame
Over 96 hours post-dose
Title
Volume of Distribution (Vz/F) of SSP-004184
Description
The distribution of a medication between plasma and the rest of the body.
Time Frame
Over 96 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years inclusive at the time of consent.
Willingness to comply with any applicable contraceptive requirements of the protocol and is:
Male, or
Non pregnant, non lactating female
Females must be at least 90 days post partum or nulliparous.
Subjects who do not have hepatic impairment (healthy subjects)
Normal renal function.
Subjects with hepatic impairment
Subjects must provide a letter of evaluation from a hepatologist or copy of supporting documents confirming the subject's hepatic impairment (a liver biopsy is preferable but not mandatory).
Hepatic impairment should be primary and must not be a complication of an underlying primary systemic disease (eg, patients with metastatic cancer and cancer cachexia)
Documented chronic stable liver impairment
Exclusion Criteria
Subjects who do not have hepatic impairment (healthy subjects)
A positive HIV antibody screen, Hepatitis B surface antigen, or Hepatitis C virus antibody screen.
Subjects with hepatic impairment
Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by an infection or drug toxicity.
Presence of surgically created or transjugular intrahepatic portal systemic shunts.
A positive HIV antibody screen.
Renal insufficiency.
All subjects
Subject has a history of thyroid disorder.
History of nephrotic syndrome.
History of alcohol or other substance abuse within the last year.
A positive screen for alcohol or drugs of abuse.
Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit = 1 beer [12 oz/355 mL] = 1 wine [5 oz/150 mL] = 1 liquor [1.5 oz/40 mL] = 0.75 oz/20 mL alcohol.)
Caffeine consumption: For healthy subjects: Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6 oz/180 mL cup of coffee, two 12 oz/355 mL (ie, 24 oz/710 mL cola) cans of cola, one 12 oz/355 mL cup of tea, three 1 oz/28 g chocolate bars (ie, 3 oz/85 g chocolate). Decaffeinated coffee, tea, or cola are not considered to contain caffeine.)
Donation of blood or blood products within 60 days.
Substantial changes in eating habits within 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Center (OCRC)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
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