Single-center, double-blind, randomized, placebo-controlled, single-ascending dose
and food interaction study to investigate the tolerability, safety, pharmacokinetics,
and pharmacodynamics of ACT-389949 in healthy male subjects

Acute inflammation is a protective response of our immune system triggered by
activities within the body that signal injury or infection. If signals that are
naturally present in our body fail to resolve (put an end to) the inflammation,
tissue damage and chronic, life-long inflammatory disease may result.
ACT-389949 is a compound that can bind to and activate a protein reported to
play a central role in the resolution of inflammation. ACT 389949 may provide a
new approach to the treatment of persistent inflammatory diseases

• to evaluate the safety and tolerability of ascending single oral doses of the
test compound ACT-389949 (test medication) in healthy male subjects

• to study how the test compound ACT-389949 is absorbed, broken-down and
excreted by the body and how it affects the functioning of the body

• to investigate whether increasing the dose of ACT-389949 with a certain
proportion results in an increase in the effect of ACT-389949 with that same
proportion

• to study the impact of food on how a single dose of ACT-389949 is absorbed,
broken-down and excreted by the body

Each dose group contains 8 healthy male subjects of which 6 will receive a
single oral dose of ACT-389949 (ranging from 1 to 1000 mg) and 2 will receive
placebo. Depending on the dose level, the drug will be administered in 1-10
capsules. Each dose level will be investigated in a new subgroup. Thus, each
subject will participate in one treatment period only, with the exception of
the subjects in the food interaction part (4th dose group), who will
participate in two treatment periods, one with medication given in fasted
condition, the other one with medication given after breakfast. The two
treatment periods will be separated by 7 to 10 days.

n.a.

With new drugs such as ACT-389949, no side effects are known yet as ACT-389949
has not been previously tested in humans. The selection of the starting dose is
based on the recommendation of the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMA).