borderline major depressive disorder
Conditions
Interventions
None listed
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 *) | — |
Countries
Netherlands
Outcome results
None listed