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SAP Depleter Dose Assessment Study in Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406314
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE July 26, 2011
First Posted Date  ICMJE August 1, 2011
Last Update Posted Date June 9, 2017
Actual Study Start Date  ICMJE October 13, 2011
Actual Primary Completion Date November 14, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • Blood concentrations of SAP [ Time Frame: 19 weeks ]
    comparison of predicted vs observed
  • Plasma concentrations of GSK2315698 [ Time Frame: 19 weeks ]
    changes in plasma concentrations of GSK2315698 over time
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • safety and tolerability of GSK2315698 [ Time Frame: 19 weeks ]
    evaluated by adverse event (AE) reporting, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG).
  • Change from baseline in blood SAP levels [ Time Frame: 19 weeks ]
    evaluate effect of GSK2315698 on SAP levels in the blood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE SAP Depleter Dose Assessment Study in Patients
Official Title  ICMJE A Phase 1, Open Label, Dose Characteristic Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Intravenous and Subcutaneous Doses of GSK2315698A in Patients With Systemic Amyloidosis
Brief Summary This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the tolerability between intravenous versus subcutaneous dose administration. The study will be carried out in patients with systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid protein (SAP) will be measured.
Detailed Description This study is an open label, dose characteristic study assessing safety and pharmacokinetic and pharmacodynamic considerations of GSK2315698A. GSK2315698A is a ligand known to bind to serum amyloid protein (SAP), a key component of an anti-SAP approach to the treatment of systemic amyloidosis. Safety assessments will include adverse events, vital signs, ECGs and other relevant clinical laboratory tests. Dose administration routes will also be determined focusing on the tolerability of intravenous dose administration versus subcutaneous. The study aims to recruit up to 30 patients with a medical diagnosis of systemic amyloidosis. Subjects will be asked to attend 2 dosing sessions, each session will involve an intravenous infusion of GSK2315698A over 48 hours followed by a single subcutaneous dose in session 1 and up to 3 subcutaneous doses in session 2 to be administered over a 24 hour period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Amyloidosis
Intervention  ICMJE Drug: GSK2315698
Intravenous infusion for approximately 48hours followed by subcutaneous injection
Study Arms  ICMJE Experimental: Intervention
Intravenous infusion for approximately 48 hours followed by subcutaneous injection
Intervention: Drug: GSK2315698
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2011)
Actual Study Completion Date  ICMJE November 14, 2012
Actual Primary Completion Date November 14, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • medically diagnosed with systemic amyloidosis
  • AST,ALT, alkaline phosphatase <= 3xULN and bilirubin ,1.5xULN
  • undergone radio-labelled-SAP scanning as part of their routine clinical care
  • male or female between 18 and 80 years of age inclusive, at time of signing the informed consent
  • subject is ambulant and capable of attending CUC
  • capable of giving written consent, which includes compliance with the requirements of the requirement and restrictions listed in the consent form
  • a female subjects is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
  • male subjects with female partners of child-bearing potential must agree to use contraception methods listed in the protocol and informed consent information. This must be followed from the time of the first dose of study medication to 85 days post-last dose.
  • smokers (<10 cigarettes a day) are permitted but must be willing to abstain for the duration of residential study sessions

Exclusion Criteria:

  • a positive pre-study Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening
  • the subject has participated in a clinical trial and has received an investigational therapeutic product (unlicensed) within 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
  • pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing
  • lactating females
  • unwillingness or inability to follow the procedures outlined in the protocol
  • subject is mentally or legally incapacitated
  • renal failure requiring haemodialysis will normally result in exclusion. Subjects in patient group 4 on haemodyalysis may be considered providing their schedule of dialysis can be accommodated within the study schedule
  • decompensated cardiac failure or recent history of syncope
  • clinically significant anaemia - Hb<9g/dL
  • use of prohibited medications
  • poor or unsuitable venous access
  • subjects with a QTc of > or equal to 480ms or other ECG abnormalities which, in the opinion of the investigator, is clinically significant in that they may increase safety risk
  • uncontrolled hypertension with systolic BP> 170mm Hg and/or diastolic >100 mm Hg
  • previous surgical procedures that result in altered anatomy of the upper digestive tract including cholecystectomy (gall bladder removal) will result in exclusion from the Entero-Test procedure, but the subject may still participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01406314
Other Study ID Numbers  ICMJE 114527
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017

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