The purpose of this study is to investigate how quickly and to what extent BI 1358894 is absorbed and eliminated from the body (this is called pharmacokinetics) when given as a single dose / multiple doses. BI 1348894 will be labelled with Carbon-14…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1:
The following pharmacokinetic parameters will be determined for BI 1358894:
- Mass balance recoveries of [14C] BI 1358894 total radioactivity in urine and
faeces after single oral dose
- Amount of radioactivity excreted as a percentage of the administered dose
(fe0-t2) for urine and faeces
Secondary outcome
Part 1:
The following pharmacokinetic parameters will be determined for total [14C] BI
1358894 and
BI 1358894 after single dose administration:
- AUC0-tz (area under the concentration-time curve of the analyte in plasma
over the time interval from 0 to the last quantifiable data point)
- Cmax (maximum measured concentration of the analyte in plasma)
Part 2:
The following pharmacokinetic parameters will be determined for BI 1358894:
- AUC0-24 (area under the concentration-time curve of the analyte in plasma
over the
time interval from 0 to 24)
- Cmax (maximum measured concentration of the analyte in plasma)
- AUC*,ss (area under the concentration-time curve of the analyte in plasma at
steady state over a uniform dosing interval *)
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady
state over a uniform dosing interval *)
Background summary
BI 1358894 is a new compound that may potentially be used for the treatment of
major depressive disorder and borderline personality disorder.
Study objective
The purpose of this study is to investigate how quickly and to what extent BI
1358894 is absorbed and eliminated from the body (this is called
pharmacokinetics) when given as a single dose / multiple doses. BI 1348894 will
be labelled with Carbon-14 (14C), this means it is made radioactive. In this
way BI 1358894 can be traced in blood, urine and feces. The breakdown products
(metabolites) of BI 1358894 will also be investigated.
Study design
Part 1:
Participation from screening until the follow-up visit will last up to
approximately 10 weeks.
The volunteer will come to the research center for:
1 screening visit
1 stay in the research center of 16 days (15 nights)
Up to 5 additional 24-hour visits
1 follow-up visit
Part 2:
Participation from screening until the follow-up visit will last up to
approximately 12 weeks.
The volunteer will come to the research center for:
1 screening visit
1 stay in the research center of 28 days (27 nights)
9 short visits to the research center
1 follow-up visit
Intervention
N/A
Study burden and risks
BI 1358894 has already been administered to humans before. In total,
approximately 217 healthy volunteers and 73 patients have received BI 1358894
in 7 previous clinical trials. In these studies, doses up to 200 mg BI 1358894
under fasted and fed conditions have been tested. These doses were safe and
were found to be well tolerated.
The most frequent side effect was headache. The intensity of headache was mild
to moderate.
Furthermore, the following side effects were observed:
Dizziness
Tiredness
For a complete overview see the protocol.
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 65 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study,
in accordance with GCP and local legislation
5. Male subjects who meet any of the following criteria from screening until 90
days after trial completion:
- Use of adequate contraception of the female partner, e.g. any of the
following methods plus condom: implants, injectables, combined oral or vaginal
contraceptives, intrauterine device that started at least two months prior to
first study drug administration or barrier method (e.g. diaphragm with
spermicide) or,
- Sexually abstinent or,
- A vasectomy performed at least 1 year prior to screening (with medical
assessment of the surgical success) or,
- Surgically sterilised female partner (including hysterectomy, bilateral tubal
occlusion, or bilateral oophorectomy) or,
- Postmenopausal female partner, defined as at least 1 year of spontaneous
amenorrhea (in questionable cases a blood sample with levels of FSH above 40
U/L and estradiol below 30 ng/L is confirmatory)
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 50 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. C-reactive protein (CRP) > upper limit of normal (ULN), liver or kidney
parameter above ULN
5. Any evidence of a concomitant disease assessed as clinically relevant by the
investigator
For 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 | EUCTR2020-002054-25-NL |
| CCMO | NL75122.056.20 |