A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of QBW251 following a single oral dose of [14C]QBW251 in healthy male subjects at steady state conditions.

QBW251 is a new compound that may eventually be used for the treatment of
chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) or other
serious lung diseases. QBW251 is a so called CFTR potentiator. CFTR stands for
cystic fibrosis transmembrane conductance regulator. CFTR forms a kind of
channel in the cell wall (~transmembrane), that regulates the flow
(~conductance) of water and salt in and out of cells in your body.

CFTR regulates the production of thin, flowing mucus. If CFTR is not working
properly this can result in thick, sticky mucus. This can affect multiple
organs, such as lungs, digestive system and reproductive organs. QBW251
enhances the function of CFTR, and this is thought to reduce the decline of
lung function in CF patients and possibly improve long function in other
serious lung diseases as well.

The purpose of this study is to investigate how safe the new compound QBW251 is
and how well it is tolerated when it is administered to healthy volunteers.
QBW251 has been administered to humans before. It has also been previously
tested in the laboratory and on animals.

It will also be investigated how quickly and to what extent the research
compound QBW251 is absorbed and eliminated from the body (this is called
pharmacokinetics). QBW251 will be labelled with 14 Carbon (14C) and this means
that it is radioactive. In this way QBW251 can be traced in blood, urine and
feces. In addition, the effect of QBW251 on the body will be investigated.

In addition, the effect of your genetic information on how the body responds to
QBW251 will be investigated (this is called pharmacogenetics). This is an
optional part of this study. If the volunteer does not wish to donate sample(s)
for genetic research, it will not prevent them from being in the study.

The actual study will consist of 1 period during which the volunteers will stay
in the research center for a maximum of 19 days (18 nights).

Day 1 is the first day of administration of the study compound. They are
expected at the research center at 14:00 h in the afternoon prior to the day of
first administration of the study compound (on Day -1).

The participation in the entire study, from the screening until the last
follow-up visit, will depend on the amount of radioactivity left in urine and
feces at the end of the study (Day 12). The amount of radioactivity in urine
and feces will be measured daily from Day 5 onwards. If, from Day 12 onwards,
the radioactivity levels in urine and feces are below the pre-defined levels,
the volunteers will be allowed to leave the research center in the morning of
Day 13. They will leave the research center on Day 18 at the latest.

They should be aware that when radioactivity levels are still above pre-defined
levels on Day 18, they will return for a maximum of 4 additional 24­hour visits
in the clinical research center: on Days 20 - 21, 23 - 24 , 26 - 27 and 32 -
33. They will be informed if these 24-hour visits will take place.

The volunteer should be aware that for the overnight visits they will have to
collect your urine and feces during the 24 hours before the visit and bring
these to the research center with them. And also during these visits the urine
and feces will be collected.

Not applicable.

Pain, minor bleedings, bruises, possibly an infection.