The purpose of this study is to investigate how quickly and to which extent the new study compound BI 690517 is absorbed, transported,and eliminated from the body. BI 690517 is an investigational study compound which has not yet been approved for…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A
- Mass balance recovery of [14C] radioactivity in urine and feces after oral
administration of BI 690517 (C-14): amount of radioactivity
excreted as a percentage of the administered dose for urine and feces over the
time interval from 0 to the last quantifiable time point, feurine,0-tz and
fefeces, 0-tz
Part B
- AUC0-* of [14C] BI 690517 (i.v.) and BI 690517 (oral)
Secondary outcome
Part A
- AUC0-tz and Cmax of [14C] radioactivity and BI 690517 in plasma
Part B
AUC0-tz and Cmax of [14C] BI 690517 (i.v.) and BI 690517 (oral) in plasma
Background summary
BI 690517 is a new compound that may potentially be used for the treatment of
chronic kidney disease. Chronic kidney disease is a
long-term condition in which kidney function declines. It is generally
associated with diabetes, high blood pressure, old age, obesity, and
cardiovascular disease. BI 690517 works by inhibiting a protein called
aldosterone synthase. The inhibition of this protein results in
multiple effects in the kidney, including reducing blood pressure in the
kidneys and improving the filtering of the blood in the kidneys. BI
690517 can possibly be used in the future to slow the progression of renal
damage and to reduce cardiovascular events in patients with
chronic kidney disease.
Study objective
The purpose of this study is to investigate how quickly and to which extent the
new study compound BI 690517 is absorbed, transported,
and eliminated from the body. BI 690517 is an investigational study compound
which has not yet been approved for clinical use.
For this study, BI 690517 is radioactively labelled with a small amount of
carbon-14 (14C) (micro dose). This means it is radioactive. In
this way, BI 690517 can be traced in blood, urine, and feces. The additional
radiation the volunteer will be exposed to in this study is
negligible. The breakdown products (metabolites) of BI 690517 will also be
investigated.
In Part A, we will investigate how the body eliminates the study compound. For
this purpose, all urine and feces will be collected after
intake of an oral solution of radioactively labeled BI 690517.
In Part B, we will investigate how the study compound is taken up by the body.
For this purpose, the uptake of a tablet containing
unlabeled BI 690517 will be studied together with an intravenous infusion of
radioactively labeled BI 690517.
Furthermore, it will be investigated how safe BI 690517 and how well it is
tolerated when it is administered to healthy men.
BI 690517 has been administered healthy subjects in 2 previous single-dose
studies and 2 multiple-dose studies. In addition, it has also
been given to patients with diabetes in another multiple-dose study. BI 690517
has also been extensively tested in the laboratory and on
animals.
Study design
Part A
The research requires the volunteer to stay in the research center for 9 days
(8 nights). This can be followed by 2 additional 24-hour
visits to the research center.
Day -1: Arrival
Day 1: Dosage of 14C labeled BI 690517 and other actions
Day 2-7: Stay at the research center for blood samples, health checks, and
urine and stool collection.
Day 8: Departure from the research center
If the additional visits are necessary, they will be on Days 14 to 15 and Days
21 to 22. After that there will be a follow-up check three
days after the last visit.
Part B
For the research it is necessary that the volunteer stays in the research
center for 4 days (3 nights).
Day -1: Arrival
Day 1: Day of administration of the study radiolabelled compound.
Day 3: Departure from the research center.
The volunteer then returns to the research center one more time for a follow-up
check.
Intervention
In Part A the volunteer will receive a single dose of 20 milligrams
radioactively labeled BI 690517(C-14) (oral solution).
In Part B the volunteer will first receive a single dose of 20 milligrams
unlabeled BI 690517 (tablets). This will be followed by a single
intravenous infusion of 100 micrograms radioactively labeled BI 690517(C-14).
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula can sometimes lead to inflammation (at the
puncture site or, rarely, in the whole body), swelling, hardening of the vein,
blood clotting with vein blockage, and bleeding in the
environment of the puncture site. Rarely, there can be damage of skin nerves
leading to paresthesia or pain. In some individuals, a
blood draw can sometimes cause pallor, nausea, sweating, low heart rate, or
drop in blood pressure with dizziness or fainting. The use
of adhesive bandages to cover blood draw sites may cause mild, temporary
redness and itching of the skin.
In total, we will take about 478 mL (Part A ) or 143 mL (Part B) of blood from
the volunteer from screening to follow-up. This amount
does not cause any problems in adults.
Heart tracing
To make a heart tracing, electrodes will be placed on the arms, chest and legs.
Prolonged use of these electrodes can cause skin
irritation.
Meals/Fasting
If the volunteer has to fast for a prolonged time during the study, this may
lead to symptoms such as dizziness, headache, stomach
upset, or fainting.
Coronavirus test
Samples for the coronavirus test will be taken from the back of the nose and
throat using swabs. Taking the samples only takes a few
seconds, but can cause discomfort and can give an unpleasant feeling. Taking a
sample from the back of your throat may cause the
volunteer to gag. When the sample is taken from the back of the nose, a
stinging sensation may be experienced and the eyes may
become watery.
Binger Strasse 173
Ingelheim am Rhein 55216
DE
Binger Strasse 173
Ingelheim am Rhein 55216
DE
Listed location countries
Age
Inclusion criteria
1. Healthy male subjects according to the assessment of the investigator, as
based on a complete medical history
including a physical examination, vital signs (BP, PR), 12-lead ECG, and
clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and
local legislation prior to admission
to the trial
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating
from normal and assessed as
clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to
140 mmHg, diastolic blood
pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of
40 to 100 bpm
3. Any laboratory value outside the reference range that the investigator
considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the
investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
Further criteria apply
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001818-18-NL |
| CCMO | NL82164.056.22 |