A phase I, open-label trial to investigate metabolism and pharmacokinetics of a single dose of [14C] BI 1358894 administered as oral solution (Part 1) and multiple doses of BI 1358894 administered as film-coated tablets (Part 2) in healthy male volunteers

Completed

• Conditions: borderline; major depressive disorder; 10027946

• Registration Number: NL-OMON49751
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified