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The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy Japanese male subjects following oral administration of multiple rising doses over 14 days.
Secondary objective is the exploration of the pharmacokinetic(s) (PK) and pharmacodynamic(s) (PD) of BI 690517 in healthy Japanese male subjects after multiple dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose group 1 | Experimental |
| |
| Dose group 2 | Experimental |
| |
| Dose group 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 690517 | Drug | 3 sequential dose groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number [N (%)] of subjects with drug-related adverse events (AEs) | Up to day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose [AUCτ,1 will be AUC0-24]) | up to 24 hours | |
| Cmax (maximum measured concentration of the analyte in plasma) |
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Inclusion Criteria:
Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Japanese ethnicity, according to the following criteria:
-- born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
Age of 20 to 50 years (incl.)
Body mass index (BMI) of 18.5 to 25.0 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Male subjects who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 90 days after trial completion:
Use of adequate contraception, e.g. any of the following methods plus condom:
--- combined oral contraceptives, intrauterine device
Vasectomised (vasectomy at least 1 year prior to enrolment)
Surgical sterilised (including hysterectomy) of the subject's female partner
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Sumida Hospital | Tokyo, Sumida-ku | 130-0004 | Japan |
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:
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| Placebo | Drug | 3 sequential dose groups |
|
| Up to 24 hours |
| AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) | After 312 hours and up to 360 hours |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | After 312 hours and up to 360 hours |