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To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo in dosing regimen 1-8 |
|
| BI 224436 dosing regimen 1 | Experimental | Dosing regimen 1 |
|
| BI 224436 dosing regimen 2 | Experimental | Dosing regimen 2 |
|
| BI 224436 dosing regimen 3 | Experimental | Dosing regimen 3 |
|
| BI 224436 dosing regimen 4 | Experimental | Dosing regimen 4 |
|
| BI 224436 dosing regimen 5 | Experimental | Dosing regimen 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 224436 | Drug | Oral drinking solution |
| |
| BI 224436 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood pressure | 1 month | |
| Changes in pulse rate | 1 month | |
| Changes in 12-lead ECG | 1 month | |
| Changes in clinical laboratory test parameters | 1 month | |
| Adverse events | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval t) | 10 days | |
| tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady-state) | 10 Days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| BI 224436 dosing regimen 6 |
| Experimental |
Dosing regimen 6 |
|
| BI 224436 dosing regimen 7 | Experimental | Dosing regimen 7 |
|
| BI 224436 dosing regimen 8 | Experimental | Dosing regimen 8 |
|
| Drug |
Oral drinking solution |
|
| BI 224436 | Drug | Oral drinking solution |
|
| BI 224436 | Drug | Oral drinking solution |
|
| BI 224436 | Drug | Oral drinking solution |
|
| BI 224436 | Drug | Oral drinking solution |
|
| BI 224436 | Drug | Oral drinking solution |
|
| BI 224436 | Drug | Oral drinking solution |
|
| BI 224436 | Drug | Oral drinking solution |
|
| Placebo | Drug | Oral drinking solution |
|
| Cmin,ss (minimum concentration of the analyte in plasma at steady-state over a uniform dosing interval t) | 10 days |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval t) | 13 days |
| t1/2,ss (terminal half-life of the analyte in plasma at steady-state) | 13 days |
| CL/F,ss (apparent clearance of the analyte in the plasma at steady-state following extravascular multiple dose administration) | 13 days |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |