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 - ADME study of BI 1358894

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

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•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)

•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

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