First Time in Human (FTIH) Study of GSK3008348 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis Patients
Status:
Completed
Trial end date:
2016-06-02
Target enrollment:
Participant gender:
Summary
GSK3008348 is an investigational drug, being developed by GlaxoSmithKline Research and
Development Limited (the Sponsor, a pharmaceutical company based in the UK) 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 which is being carried out on behalf of
the Sponsor by Quintiles. The primary purpose of Part A is to examine the safety and
tolerability of 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.