SAP Depleter Dose Escalation Study in Healthy Volunteers

NCT01323985 | Completed Phase 1

• 1 other identifier: 113776
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (2)

• An assessment of the safety and tolerability of single intravenous dose of GSK2315698

  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)

  12 weeks

Secondary Outcomes (3)

• Measure the pharmacokinetics of IV administration of GSK2315698

  12 weeks

• Measure depletion of SAP following IV administration of GSK2315698

  12 weeks

• Measure the kinetics of SAP production and SAP degradation in healthy volunteers

  12 weeks

Study Arms (1)

GSK2315698

EXPERIMENTAL

Intravenous infusion single dose

Drug: GSK2315698

Interventions

GSK2315698 DRUG

5mg-400mg IV (in the vein) single dose over 1-4 hours

GSK2315698

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

Location

Related Links

• Results for study 113776 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Amyloidosis

Interventions

miridesap

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 28, 2011
• Study Start: January 6, 2011
• Primary Completion: June 30, 2011
• Study Completion: June 30, 2011
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

GB (1)