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Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 207127 NA | Experimental | fixed sequence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 207127 NA | Drug | Days 3-8 and days 25-30 |
| |
| BI 201335 NA |
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state Cmax (Maximum measured concentration of the analyte in plasma) | up to day 31 | |
| Steady-state AUC (Area under concentration-time curve) | up to day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for several time points | up to day 31 | |
| Tmax (Time from dosing to the maximum measured concentration of the analyte in plasma) | up to day 31 | |
| Cx for several time points |
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Inclusion Criteria:
Exclusion criteria:
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D014044 | Tolbutamide |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Days 15-30 |
|
| Midazolam | Drug | Days 1, 7, 23 and 29 |
|
| Tolbutamide | Drug | Days 1, 7, 23 and 29 |
|
| up to day 31 |
| AUC for several time points | up to day 31 |
| CL/F (Total apparent clearance of the analyte in plasma following extravascular administration) for several time points | up to day 31 |
| V/F (Apparent volume of distribution during following an extravascular dose) for several time points | up to day 31 |
| t1/2 (Terminal half-life of the analyte in plasma) | up to day 31 |
| Cavg0-24 | up to day 31 |
| Ratio for Cmax,Met at several time points | up to day 31 |
| Ratio for AUC at several time points | up to day 31 |
| Tlast,N | up to day 31 |
| Ae (amount of analyte eliminated in urine for different time points) | up to day 29 |
| CLR (renal clearance of the analyte for different time points) | up to day 29 |
| fe (fraction of analyte eliminated in urine for different time points) | up to day 29 |
| Number of patients with adverse events | up to 66 days |
| Assessment of tolerability on a 4-pointe scale by investigator | within 14 days after last drug administration |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |