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

NCT ID: NCT01732263

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-09
• Study Completion Date: 2013-04-01

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.

Conditions

Hepatic Impairment; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SSP-004184 (Child-Pugh A Liver Impaired)

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.

Group Type: EXPERIMENTAL

SSP-004184

Intervention Type: DRUG

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

SSP-004184 (Child-Pugh B Liver Impaired)

Group Type: EXPERIMENTAL

SSP-004184

Intervention Type: DRUG

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

SSP-004184 (Child-Pugh C Liver Impaired)

Group Type: EXPERIMENTAL

SSP-004184

Intervention Type: DRUG

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

SSP-004184 (Matched Healthy Subjects)

Group Type: EXPERIMENTAL

SSP-004184

Intervention Type: DRUG

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

Interventions

SSP-004184

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

Intervention Type: DRUG

Other Intervention Names

SPD602, FBS0701

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center (OCRC)

Orlando, Florida, United States

Countries

United States

Other Identifiers

SPD602-105

Identifier Type: -

Identifier Source: org_study_id