Multiple, ascending oral dose, safety and tolerability of ACT-389949
Research type
Research Study
Full title
A single-center, double-blind, parallel-group, randomized, placebo-controlled, multiple ascending oral dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy subjects.
IRAS ID
116405
Contact name
Adrian Johnston Stewart
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2012-003582-18
Research summary
Currently, glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) are the mainstays of anti-inflammatory treatment. Both classes of drugs have pleiotropic effects: e.g., long-term glucocorticoid use increases the risk of osteoporosis, diabetes, and opportunistic infection. NSAIDs increase the risk of gastrointestinal bleeding and of adverse cardiovascular events. It is thought that an FPR2 agonist, by enhancing endogenous, pro-resolution pathways, might have an improved efficacy to tolerability ratio compared with current therapies. This study will be composed of 3 Parts: In Part A, the safety, tolerability, pharmacokinetics and pharmacodynamics following once a day oral dosing of ACT 389949 for 9 days at 3 ascending dose levels in healthy male and female subjects of non-childbearing potential will be evaluated. In Part B, the safety, tolerability, pharmcodynamics and pharmacokinetics of ACT 389949 following a maximum of two different oral dosing regimens will be evaluated: ACT 389949 given either every 3 days for 13 days or every 2 days for 9 days (5 doses for each regimen) in healthy male and female subjects of non-childbearing potential. In Part C, if required, to provide additional information, to that obtained from Parts A and B in terms of safety, tolerability, PK, PD, and/or the potential effect of ACT-389949 to inhibit cell infiltration following inhaled lipopolysaccharide(LPS). This study will be performed as a prospective, double-blind, parallel-group, randomized, placebo-controlled, multiple-ascending oral dose Phase 1 study, performed at one UK site in up to 91 healthy volunteers.
REC name
HSC REC A
REC reference
12/NI/0145
Date of REC Opinion
18 Oct 2012
REC opinion
Further Information Favourable Opinion