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

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ClinicalTrials.gov Identifier: NCT01732263
Recruitment Status : Completed
First Posted : November 22, 2012
Results First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE November 19, 2012
First Posted Date  ICMJE November 22, 2012
Results First Submitted Date  ICMJE April 16, 2014
Results First Posted Date  ICMJE May 15, 2014
Last Update Posted Date May 15, 2014
Study Start Date  ICMJE December 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
  • Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184 [ Time Frame: 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 [ Time Frame: 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.
  • Time of Maximum Plasma Concentration (Tmax) for SSP-004184 [ Time Frame: Over 96 hours post-dose ]
    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 [ Time Frame: 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 [ Time Frame: Over 96 hours post-dose ]
    The rate at which a drug is removed from the body.
  • Volume of Distribution (Vz/F) of SSP-004184 [ Time Frame: Over 96 hours post-dose ]
    The distribution of a medication between plasma and the rest of the body.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2012)
  • 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 ]
  • Maximum Plasma Concentration (Cmax) of SSP-004184 (SPD602) [ Time Frame: Assessed over a 96-hour period from post-dose on Day 1 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatic Impairment
  • Healthy
Intervention  ICMJE Drug: SSP-004184
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Other Name: SPD602, FBS0701
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: SSP-004184
  • Experimental: SSP-004184 (Child-Pugh B Liver Impaired)
    Intervention: Drug: SSP-004184
  • Experimental: SSP-004184 (Child-Pugh C Liver Impaired)
    Intervention: Drug: SSP-004184
  • Experimental: SSP-004184 (Matched Healthy Subjects)
    Intervention: Drug: SSP-004184
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2013)
44
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2012)
48
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01732263
Other Study ID Numbers  ICMJE SPD602-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Lasseter, MD Clinical Pharmacology of Miami
PRS Account Shire
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP