The purpose of this study is to investigate how quickly and to what extent BAY 1817080 is absorbed and eliminated from the body. BAY 1817080 will be labeled with Carbon-14 (14C) and is thus radioactive. In this way BAY 1817080 and its breakdown…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronic cough, Endometriosis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A
• To assess the pharmacokinetics of a single oral dose of BAY 1817080 given as
a solution in healthy men.
Part B
• To determine the mass balance and route of excretion, to measure the
cumulative amount as well as the time course of drug-related, radiolabeled
material excreted in the urine and feces following a single oral dose of
[14C]BAY 1817080 given as a solution in healthy men.
• To quantify the total radioactivity in blood and plasma.
• To quantify unchanged BAY 1817080 in plasma.
Secondary outcome
Parts A and B
• To assess the safety and tolerability of a single oral dose of BAY 1817080
(Part A) and [14C]BAY 1817080 (Part B) given as a solution in healthy men.
Background summary
BAY 1817080 is a new compound that may potentially be used for the treatment of
chronic cough and other conditions, such as endometriosis, neuropathic pain,
and bladder disorders.
Study objective
The purpose of this study is to investigate how quickly and to what extent BAY
1817080 is absorbed and eliminated from the body. BAY 1817080 will be labeled
with Carbon-14 (14C) and is thus radioactive. In this way BAY 1817080 and its
breakdown products (metabolites) can be traced in blood, urine and feces. It
will also be investigated how safe BAY 1817080 is and how well it is tolerated
when it is administered to healthy volunteers.
Study design
Prior to receiving the study compound on the day of dosing (Day 1), the
volunteer has to fast during the night for at least 10 hours. After this, the
volunteer will be given a high fat, high calorie breakfast. This breakfast must
be consumed entirely within 30 minutes. The volunteer will then receive 50
milligram (mg) of BAY 1817080 30 minutes after the start of the breakfast. BAY
1817080 will be given as an oral solution of 20 mL. After administration of the
study compound, the vial will be rinsed twice with water, which the volunteer
will also be required to drink. Thereafter, the volunteer is also required to
drink an additional amount of water so that in total 240 mL of water is
ingested.
Intervention
Part A:
Day Description
-1 Entry in the research center
1 Administration of 50 mg BAY 1817080 and other procedures (see below)
2 and 3 Stay in the research center for blood samples and health checks
4 Leave the research center
Part B:
Day Description
-1 Entry in the research center
1 Administration of 50 mg 14C-labeled BAY 1817080 and other procedures
(see below)
2-14 Stay in the research center for blood samples, health checks, and
the collection of urine and feces
15 Leave the research center
22* 24-hour stay to collect urine and feces and to perform other
procedures (see below)
29* 24-hour stay to collect urine and feces and to perform other
procedures (see below)
36* 24-hour stay to collect urine and feces and to perform other
procedures (see below)
43* 24-hour stay to collect urine and feces and to perform other
procedures (see below)
* These visits are only needed if you did not meet the excretion criteria on
the previous visit.
Study burden and risks
The study compound may cause side effects.
The so far observed side effect is taste disturbance. About 20% of participants
of previous studies who were exposed to BAY 1817080 have reported taste
perception-related changes. These were mostly mild in intensity, and none of
the participants discontinued the study because of these changes. Changes were
fully reversible after the end of treatment.
The following effects have been observed in single cases in humans, animal
tests and/or in vitro laboratory tests (this means tests outside of the body)
but it is not known yet whether it is related to BAY 1817080 and/or whether it
is meaningful for patients. These potential study compound effects are:
• Increase in Antithrombin III activity
Antithrombin III is a protein which inhibits blood clotting. A slight increase
in its activity has been observed after administration of BAY 1817080.
Volunteers who received BAY 1817080 did not feel this change and it did not
lead to any medical events like bleeding or bruising. The responsible doctor
will regularly measure blood clotting parameters (laboratory tests) during the
study.
• Potential decrease in heart rate and diastolic blood pressure
A small decrease in diastolic blood pressure (4-7 mmHg) and heart rate (5-11
beats per minute) was observed. Volunteers who received BAY 1817080 did not
feel this change and it did not lead to any related medical events, such as
dizziness or fainting. The responsible doctor will regularly measure blood
pressure and heart rate during the study.
• Potential changes in liver function laboratory values
Based on laboratory tests there is a possibility of liver dysfunction due to
BAY 1817080. However, no liver dysfunction due to BAY 1817080 has been observed
in humans. Your laboratory values will be assessed during the study. Results
may trigger the need for additional laboratory tests.
• Potential irritation of skin and/or eye due to sunlight
Based on laboratory experiments, BAY 1817080 might cause skin and/or eye
irritation after prolonged exposure to intensive sunlight. Your skin may become
more sensitive to getting a sunburn. However, no such events occurred in
clinical studies with BAY 1817080 thus far. As a precaution, you should avoid
excessive exposure to sunlight during treatment with BAY 1817080. Please use
conventional ultraviolet (UV) sunscreens, sunglasses and avoid prolonged
sunbathing and use of solarium.
The study compound may also have side effects that are still unknown.
Kaiser-Wilhelm-Allee 1
Leverkusen 51368
DE
Kaiser-Wilhelm-Allee 1
Leverkusen 51368
DE
Listed location countries
Age
Inclusion criteria
1. Capable of giving signed informed consent as described in Appendix 10.1.4,
which includes compliance with the requirements and restrictions listed in the
ICF and in this protocol;
2. Ability to understand and follow study-related instructions;
3. Participant has signed the ICF before any study specific tests or procedures
are done;
4. Healthy male participant;
5. Age: 18 to 65 years (inclusive) at the time of informed consent and first
dose of study medication
For the complete overview see the protocol
Exclusion criteria
1. Presence or history of clinically relevant cardiovascular, central nervous
system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or
endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension,
seizures, or allergic skin rash;
2. Known hypersensitivity to the study drugs (active substances or excipients
of the preparations);
3. Known severe allergies, e.g., allergies to more than 3 allergens, allergies
affecting the lower respiratory tract (e.g., allergic asthma), allergies
requiring therapy with corticosteroids or significant non-allergic drug
reactions;
4. Febrile illness within 1 week before study drug administration;
5. Current or recent (within 6 months) gastrointestinal disease that would be
expected to influence the absorption of drugs (i.e., a history of
malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis,
frequent occurrence of heartburn [more than once per week], or any
gastrointestinal surgical intervention [e.g. cholecystectomy]);
For the complete overview see the protocol
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 | EUCTR2020-000519-54-NL |
| CCMO | NL74231.056.20 |