Single center, open label, non-randomized, non-placebo controlled study to investigate the pharmacokinetics, metabolic disposition, and mass balance after single administration of 20 mg [14C]neladenoson bialanate (oral solution) in healthy male subjects.

Neladenoson bialanate is a new investigational compound that may eventually be
used for the treatment of chronic heart failure. Neladenoson bialanate is a
so-called prodrug. This means that it is not active by itself, but it becomes
active after it has been absorbed and processed by the body. The active
compound is able to bind to a specific protein present on several cell types in
the body, including cardiac muscle cells. It has been shown that due to the
binding of the activated compound to the cardiac muscle cells, the condition
and the function of the cardiac muscle cells is
improved. Neladenoson bialanate is in development and is not registered as a
drug but has been given to humans before.

The purpose of the study is to investigate how quickly and to what extent
neladenoson bialanate is absorbed, distributed, metabolized (broken down) and
eliminated from the body (this is called pharmacokinetics). Neladenoson
bialanate to be administered will be labeled with 14-Carbon (14C) and is thus
radioactive (also called radiolabeled). In this way neladenoson bialanate can
be traced in blood, urine and feces. It will also be investigated to what
extent neladenoson bialanate is tolerated. This study will be performed in 6
healthy male volunteers. This study is not intended to improve the health, but
is necessary for the further development of neladenoson bialanate.

The actual study will consist of 1 period during which the volunteers will stay
in the clinical research center in Groningen (location Martini Hospital) for a
maximum of 16 days (15 nights) followed by 1 day during which they will visit
the clinical research center in Groningen for a short visit and one follow up
visit. Day 1 is the day of administration of study compound. They are expected
at the clinical research center at 11:00 h in the morning prior to the day of
administration of the study compound. The volunteers will be required not to
have consumed any food or drinks during the 10 hours prior to arrival in the
clinical research center (with the exception of water). The participation to
the entire study, from the pre-study screening until the follow-up, will depend
on the amount of radioactivity left in urine and feces on Day 11. The amount of
radioactivity in urine and feces will be measured from Day 1 onwards. If, from
Day 11 onwards, the radioactivity levels in urine and feces are below the
pre-defined levels, they will be allowed to leave the clinical research center.
If the radioactivity levels in urine and feces are still above the pre-defined
levels
on Day 11, they will have to stay in the clinical research center for 4
additional days at the maximum. This means that they will leave the clinical
research center between Day 11 and Day 15. The volunteers should be aware that
when the radioactivity levels are still above the pre-defined levels on Day 15,
additional short periods on Day 21, Day 28, Day 35 and Day 42 (of 24 hours per
period) may be scheduled for the collection of urine and/or feces until the
radioactivity levels are below the pre-defined levels. On these additional
days, they are expected at the clinical research center at 10:30 h in the
morning.

They will return to the clinical research center on Day 29 for a short visit.
The follow-up will take place 6 weeks after the day they received the study
compound. The appointment for the follow-up will be made as soon as it is known
when the study will end for the volunteer. The participation in the entire
study, from the pre-study screening will be a maximum of 10 weeks.

Not applicable.

Pain, minor bleedings, bruises, possibly an infection.