Last updated: 11/07/2018 07:49:30
SAP depleter dose assessment study in patients
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Blood concentrations of SAP
Timeframe: 19 weeks
Plasma concentrations of GSK2315698
Timeframe: 19 weeks
Secondary outcomes:
safety and tolerability of GSK2315698
Timeframe: 19 weeks
Change from baseline in blood SAP levels
Timeframe: 19 weeks
Interventions:
Enrollment:
17
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
T Sahota, A Berges, S Barton, L Cookson, S Zamuner,D Richards.Target Mediated Drug Disposition Model of CPHPC in Patients with Systemic Amyloidosis.CPT Pharmacometrics Syst Pharmacol.2015;4(2):1-11
Medical condition
Amyloidosis
Product
miridesap
Collaborators
Not applicable
Study date(s)
October 2011 to November 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- medically diagnosed with systemic amyloidosis
- AST,ALT, alkaline phosphatase <= 3xULN and bilirubin ,1.5xULN
- 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)
Inclusion and 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
Trial location(s)
Location
GSK Investigational Site
Cambridge, United Kingdom, CB2 2GG
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-14-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 114527 can be found on the GSK Clinical Study Register.
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