A study to assess the safety, tolerability, PK and PD of LAS190792
Research type
Research Study
Full title
A 2-PART, RANDOMISED, PLACEBO-CONTROLLED, SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF LAS190792 DELIVERED BY INHALATION IN ASTHMATIC AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) SUBJECTS.
IRAS ID
132753
Contact name
Tim Mant
Contact email
Sponsor organisation
Almirall S.A.
Eudract number
2013-001758-93
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
LAS190792 is a new chemical entity possessing long-acting dual-pharmacology activity (muscarinic receptor antagonism and beta2 adrenoceptor agonism (MABA) in a single molecule, which is being developed by Almirall for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and potentially asthma. Blocking of these receptors by other drugs has been shown to be of value in the management of asthma / COPD. The study has two parts; a single ascending dose study in males volunteers with mild persistent asthma and a 5 way crossover (each patient takes a different dose / medication on each of the 5 occasions), single dose study in males and non-childbearing women volunteers with moderate to severe COPD. The purpose of the study is to examine the safety, tolerability, the pharmacodynamics (what the drug does to the body) and pharmacokinetics (the way the body handles absorbs, distributes, breaks down and excretes) various doses of LAS190792 in patients with mild persistent asthma and patients with moderate to severe COPD. This will be the first time LAS190792 has been given to human subjects, and the study has been designed to provide data on which to base future work to establish the safety, the tolerability and the efficacy profile of LAS190792 in treating patients with asthma and COPD.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
13/WM/0292
Date of REC Opinion
21 Aug 2013
REC opinion
Further Information Favourable Opinion