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The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 207127 NA | Experimental | single rising dose part |
|
| Placebo | Placebo Comparator |
| |
| BI 207127 NA, fasted or fed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| BI 207127 NA powder for solution |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with abnormal findings in physical examination | Baseline, within 14 days after last trial procedure | |
| Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR) | Baseline, up to 14 days after last trial procedure | |
| Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram) | Baseline, up to 14 days after last trial procedure | |
| Number of patients with abnormal changes in clinical laboratory tests | Baseline, up to 14 days after last trial procedure | |
| Number of patients with adverse events | up to 44 days | |
| Assessment of tolerability on a 4-point scale by investigator | within 14 days after last trial procedure |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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|
| BI 207127 NA tablet | 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 |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to the last observed plasma concentration) | 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 |
| MRToral (mean residence time of the analyte in the body after oral administration) | up to 72 hours after drug administration |
| CL/F (apparent clearance of the analyte in plasma after oral administration) | up to 72 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an oral 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 |