Last updated: 11/07/2018 06:45:43
SAP depleter dose escalation study in healthy volunteers
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 1 dose escalation study to investigate the pharmacokinetics, pharmacodynamics, safety, and tolerability of single intravenous doses of GSK2315698A in healthy volunteers
Trial description: The purpose of this study is to provide safety information and to define the optimal induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in healthy volunteers prior to assessing in patients
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
An assessment of the safety and tolerability of single intravenous dose of GSK2315698
Timeframe: 12 weeks
To characterize the PK/PD relationship GSK2315698 in order to define an intravenous dosing regimen that provides optimal depletion of blood SAP over a 24 hour period (in healthy volunteers)
Timeframe: 12 weeks
Secondary outcomes:
Measure the pharmacokinetics of IV administration of GSK2315698
Timeframe: 12 weeks
Measure depletion of SAP following IV administration of GSK2315698
Timeframe: 12 weeks
Measure the kinetics of SAP production and SAP degradation in healthy volunteers
Timeframe: 12 weeks
Interventions:
Enrollment:
21
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)
January 2011 to June 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Inclusion and exclusion criteria
Inclusion criteria:
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject 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 [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]. (As a precaution a pregnancy test will be conducted prior to dosing; a positive test will lead to exclusion).
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Protocol Section 8.1. This criterion must be followed from the time of the first dose of study medication until 85 days post-last dose.
- Body weight gretaer than or equal to 50 kg and BMI within the range 19 – 30 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTc, < 450 msec
- Peripheral veins suitable for venous blood sampling and cannulation
- Smokers (<10 /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 positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Previous surgical procedures on the upper digestive tract including cholecystectomy (gallbladder removal), and/or cholelithotomy (gallstone removal).
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 84 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial location(s)
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
2011-30-06
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 113776 can be found on the GSK Clinical Study Register.
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