SAP Depleter Dose Assessment Study in Patients

• Status: Completed
• Trial end date: 2012-11-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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