SAP Depleter Dose Assessment Study in Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01406314
• Date of registration: 26/07/2011
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: SAP Depleter Dose Assessment Study in Patients
• Scientific title: 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
• Date of first enrolment: October 13, 2011
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01406314
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyloidosis

Intervention(s)

Drug: GSK2315698

Primary Outcome(s)

Blood concentrations of SAP [Time Frame: 19 weeks]

Plasma concentrations of GSK2315698 [Time Frame: 19 weeks]

Secondary Outcome(s)

Change from baseline in blood SAP levels [Time Frame: 19 weeks]

safety and tolerability of GSK2315698 [Time Frame: 19 weeks]

Secondary ID(s)

114527

Source(s) of Monetary Support

Please refer to primary and secondary sponsors