NCT01406314

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 13, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2012

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

July 26, 2011

Last Update Submit

June 7, 2017

Conditions

Amyloidosis

Keywords

Phase 1PatientSystemic AmyloidosisAmyloidosis

Outcome Measures

Primary Outcomes (2)

  • Blood concentrations of SAP

    comparison of predicted vs observed

    19 weeks

  • Plasma concentrations of GSK2315698

    changes in plasma concentrations of GSK2315698 over time

    19 weeks

Secondary Outcomes (2)

  • safety and tolerability of GSK2315698

    19 weeks

  • Change from baseline in blood SAP levels

    19 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Intravenous infusion for approximately 48 hours followed by subcutaneous injection

Drug: GSK2315698

Interventions

GSK2315698DRUG

Intravenous infusion for approximately 48hours followed by subcutaneous injection

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

Location

Related Links

MeSH Terms

Conditions

AmyloidosisImmunoglobulin Light-chain Amyloidosis

Interventions

miridesap

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 1, 2011

Study Start

October 13, 2011

Primary Completion

November 14, 2012

Study Completion

November 14, 2012

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

GB(1)