Verona initiates US clinical pharmacokinetic study for RPL554
Source - SMW
Verona Pharma has announced the initiation of a clinical pharmacokinetic trial in the US for its product candidate RPL554, following the acceptance of an Investigational New Drug application (IND) by the US FDA.
The first subjects had been enrolled and dosed in the study.
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, and is currently in development for the treatment of chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).
This complete block two-way crossover trial will investigate the oral bioavailability and pharmacokinetics (PK) of nebulized RPL554 in 12 healthy volunteers.
The study would also assess the tolerability and safety of single nebulized doses of RPL554.
The oral bioavailability examines the potential contribution arising from the absorption of the swallowed portion of a nebulized dose of RPL554 to its systemic bioavailability. Top-line data is expected in the fourth quarter 2017.