- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01406314
SAP Depleter Dose Assessment Study in Patients
June 7, 2017 updated by: GlaxoSmithKline
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
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.
Study Overview
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
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cambridge, United Kingdom, CB2 2GG
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Intravenous infusion for approximately 48 hours followed by subcutaneous injection
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Intravenous infusion for approximately 48hours followed by subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood concentrations of SAP
Time Frame: 19 weeks
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comparison of predicted vs observed
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19 weeks
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Plasma concentrations of GSK2315698
Time Frame: 19 weeks
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changes in plasma concentrations of GSK2315698 over time
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19 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety and tolerability of GSK2315698
Time Frame: 19 weeks
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evaluated by adverse event (AE) reporting, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG).
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19 weeks
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Change from baseline in blood SAP levels
Time Frame: 19 weeks
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evaluate effect of GSK2315698 on SAP levels in the blood
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19 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 13, 2011
Primary Completion (ACTUAL)
November 14, 2012
Study Completion (ACTUAL)
November 14, 2012
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
July 28, 2011
First Posted (ESTIMATE)
August 1, 2011
Study Record Updates
Last Update Posted (ACTUAL)
June 9, 2017
Last Update Submitted That Met QC Criteria
June 7, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114527
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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