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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01732263
First received: November 19, 2012
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hepatic Impairment
Healthy Subjects
Drug: SPD602 (FBS0701, SSP-004184)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Shire:

Primary Outcome Measures:
  • Area Under the Plasma Concentration Versus Time Curve (AUC) of SSP-004184 (SPD602) [ Time Frame: Assessed over a 96-hour period from post-dose on Day 1 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of SSP-004184 (SPD602) [ Time Frame: Assessed over a 96-hour period from post-dose on Day 1 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD602 (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.
Drug: SPD602 (FBS0701, SSP-004184)
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Other Name: SPD602, FBS0701, SSP-004184
Experimental: SPD602 (Child-Pugh B Liver Impaired) Drug: SPD602 (FBS0701, SSP-004184)
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Other Name: SPD602, FBS0701, SSP-004184
Experimental: SPD602 (Child-Pugh C Liver Impaired) Drug: SPD602 (FBS0701, SSP-004184)
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Other Name: SPD602, FBS0701, SSP-004184
Experimental: SPD602 (Matched Healthy Subjects) Drug: SPD602 (FBS0701, SSP-004184)
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Other Name: SPD602, FBS0701, SSP-004184

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732263

Locations
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Orlando Clinical Research Center (OCRC)
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Kenneth Lasseter, MD Clinical Pharmacology of Miami
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01732263     History of Changes
Other Study ID Numbers: SPD602-105
Study First Received: November 19, 2012
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014