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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 653048 H3PO4 solution | Experimental | single rising doses |
|
| BI 653048 H3PO4 low dose capsule | Experimental |
| |
| BI 653048 H3PO4 high dose capsule | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 653048 H3PO4 solution | Drug |
| ||
| BI 653048 H3PO4 low dose capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinically significant findings in vital signs | blood pressure (BP), pulse rate (PR) respiratory rate (RR), oral body temperature (T), orthostatic test | up to 10 days after drug administration |
| Number of patients with clinically significant findings in ECG | up to 10 days after drug administration | |
| Number of patients with clinically significant findings in laboratory tests | up to 10 days after drug administration | |
| Number of patients with adverse events | up to 10 days after drug administration | |
| Assessment of tolerability performed by the investigator on a four-point scale | up to 10 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 72 hours after drug administration | |
| tmax (time from dosing to maximum measured concentration) | up to 72 hours after drug administration |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30908082 | Derived | Harcken C, Scholl P, Nabozny G, Thomson D, Bianchi D. Clinical profile of the functionally selective glucocorticoid receptor agonist BI 653048 in healthy male subjects. Expert Opin Investig Drugs. 2019 May;28(5):489-496. doi: 10.1080/13543784.2019.1599859. Epub 2019 Apr 9. |
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| Drug |
|
| BI 653048 H3PO4 high dose capsule | Drug |
|
| Placebo | Drug |
|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 72 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 72 hours after drug administration |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 72 hours after drug administration |
| AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) | up to 72 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 72 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72 hours after drug administration |
| MRTp.o. (mean residence time of the analyte in the body after oral administration) | up to 72 hours after drug administration |
| CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) | up to 72 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours after drug administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 48 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 48 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 48 hours after drug administration |
| Dose-normalised Cmax | up to 72 hours after drug administration |
| Dose-normalized AUC0-∞ | up to 72 hours after drug administration |
| Emax (maximum measured concentration of the biomarker in blood or serum) | up to 72 hours after drug administration |
| Emin (minimum measured concentration of the biomarker in blood or serum) | up to 72 hours after drug administration |
| Tmin (time from dosing to minimum measured concentration of the biomarker) | up to 72 hours after drug administration |
| Tmax (time from dosing to maximum measured concentration of the biomarker) | up to 72 hours after drug administration |
| AUECt1-t2 (area under the concentration-time curve of the biomarker in the blood over the time interval from t1 to t2) | up to 72 hours after drug administration |
| AUECbelow_base (area under the baseline corrected concentration-time curve of the biomarker) | up to 72 hours after drug administration |
| AUECabove_base (area above the baseline corrected concentration-time curve of the biomarker) | up to 72 hours after drug administration |
| Expression of glucocorticoid responsive genes | up to 72 hours after drug administration |