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

Phase 1

Completed

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.

Recruitment & Eligibility

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)

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
SSP-004184 (Child-Pugh A Liver Impaired)	SSP-004184	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)	SSP-004184	-
SSP-004184 (Matched Healthy Subjects)	SSP-004184	-
SSP-004184 (Child-Pugh C Liver Impaired)	SSP-004184	-

Primary Outcome Measures

Name	Time	Method
Time of Maximum Plasma Concentration (Tmax) for SSP-004184	Over 96 hours post-dose	Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184	Over 96 hours post-dose	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	Over 96 hours post-dose	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.
Plasma Half-Life (T 1/2) of SSP-004184	Over 96 hours post-dose	The time it takes for the blood plasma concentration of a substance to halve.
Total Body Clearance (CL/F) of SSP-004184	Over 96 hours post-dose	The rate at which a drug is removed from the body.
Volume of Distribution (Vz/F) of SSP-004184	Over 96 hours post-dose	The distribution of a medication between plasma and the rest of the body.

Secondary Outcome Measures

Name	Time	Method

Locations (2): Clinical Pharmacology of Miami
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Miami, Florida, United States
Orlando Clinical Research Center (OCRC)
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Orlando, Florida, United States