200262 - A FTIH study with GSK3008348
Research type
Research Study
Full title
A FTIH study with GSK3008348 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
190762
Contact name
Tim Mant
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2015-001470-17
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
GSK3008348 is an investigational drug, being developed by GlaxoSmithKline Research and Development Limited, (the Sponsor, a pharmaceutical company based in the UK) and this study is being carried out on behalf of the Sponsor by Quintiles. GSK3008348 is an investigational drug that may be useful for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare and poorly understood disease that causes scarring of the lungs. The main symptoms are shortness of breath and a dry cough. Symptoms generally worsen over time and in some subjects may prove fatal. The cause of IPF is unknown.
This is a First Time in Human, Phase 1, 3-part, study.
The primary purpose of Part A is to examine the safety and tolerability following single nebulised (a medicated spray) doses of GSK3008348 following inhalation in healthy volunteers. The secondary objective is to determine how and at what rate the body absorbs, distributes, breaksdown and eliminates the drug.Parts B and C of this study will be in patients with Idiopathic Pulmonary Fibrosis(IPF).
The purpose of Part B and C is to examine the safety and tolerability, and how much of the drug binds to its target, following single nebulised (a medicated spray) doses of GSK3008348 following inhalation in patients with Idiopathic Pulmonary Fibrosis (IPF). The secondary objective is to determine how and at what rate the bodies of these patients absorbs, distributes, breaksdown and eliminates the drug.
The total duration of Part A will be 65-87 days, Part B 62 days and Part C 43 days.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0641
Date of REC Opinion
19 Nov 2015
REC opinion
Favourable Opinion