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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006992-41 | EudraCT Number |
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The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy female subjects of non-childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1819479 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1819479 | Drug | BI 1819479 |
| |
| BI matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | up to 106 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss) | up to 92 days | |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) |
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Inclusion Criteria:
Healthy female subjects of non-childbearing potential according to the assessment of the investigator, as 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
Age between 18 years and 67 (inclusive)
Body mass index (BMI) of 18.5 to 30.9 (weight divided by height squared)(kg/m2) (inclusive)
Signed and dated written informed consent in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Female subject of non-childbearing potential defined as:
Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
Postmenopausal, defined as no menses for 1 year in women aged = 51 years or no menses for 2 years in women aged = 50 years, without an alternative medical cause
In questionable cases of postmenopausal status:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency
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| Drug |
BI matching placebo |
|
| up to 92 days |