Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003814-42 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Experimental | single dose BI 691751 |
|
| Test | Experimental | multiple doses of itraconazole + single dose BI 691751 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| itraconazole | Drug | multiple doses of itraconazole given as capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration) | AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration. | from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h. |
| Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood) | Cmax (maximum measured concentration of BI 691751 in plasma and whole blood). | From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity) | AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity). | from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1334.10.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Itraconazole (IT) +BI 691751 / BI 691751 | Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2. The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks. Oral administration with 240 mL water after intake of a standardised meal. |
| FG001 | BI 691751 / IT+BI 691751 | Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2. Oral administration with 240 mL water after intake of a standaridsed meal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
Treated Set (TS): included all subjects who were randomized and took at least one dose of study medication during the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Itraconazole (IT) +BI 691751 / BI 691751 | Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2. The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks. Oral administration with 240 mL water after intake of a standardised meal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration) | AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration. | Pharmacokinetic Set (PKS): included all subjects from the TS who provided at least one primary or secondary pharmacokinetic endpoint in any period that is judged as evaluable for pharmacokinetics and is not affected by protocol violations relevant to the statistical evaluation of bioavailability | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h. |
|
From the 1st trial drug administration of a treatment until the 1st trial drug intake in the next treatment or until 31 days after the last administration of BI were assigned to the respective on-treatment phases (BI alone, loading IT, BI + further IT)
More specifically, for: BI 691751 - up to 50 days, Loading IT - 3 days, BI + further IT - up to 47 days
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 691751 | 10 mg single dose oral administration with 240 mL water after intake of a standard meal. (only in the reference treatment period) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BI 691751 |
| Drug |
single dose BI 691751 given as tablet |
|
| BI 691751 | Drug | single dose BI 691751 given as tablet |
|
| NOT COMPLETED |
|
| BG001 | BI 691751 / IT+BI 691751 | Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2. Oral administration with 240 mL water after intake of a standaridsed meal. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
single dose BI 691751 BI 691751: 10 mg single dose oral administration with 240 mL water after intake of a standard meal. |
| OG001 | IT + BI 691751 | Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal. |
|
|
|
| Primary | Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood) | Cmax (maximum measured concentration of BI 691751 in plasma and whole blood). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h. |
|
|
|
|
| Secondary | AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity) | AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h. |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Loading Itraconazole (IT) | 200 mg of itraconazole (introductory treatment with itraconazole over three days, prior to the first administration of BI 691751 only in the test treatment period). | 0 | 20 | 0 | 20 |
| EG002 | BI 691751 + Further IT | 10 mg of BI 691751 in combination with multiple oral doses of itraconazole (only in the test treatment period after the introductory treatment with itraconazole alone over three days). | 0 | 20 | 0 | 20 |
| EG003 | Total BI 691751 | total subjects with BI 691751 treatment (either BI 691751 alone or IT+BI 691751) | 0 | 20 | 0 | 20 |
| EG004 | Total on Treatment | combination of BI 691751, loading IT and BI 691751+ further IT. | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D010879 |
| Piperazines |
| gMean ratio of test to reference treatment (in whole blood) | gMean ratio | 93.54 | Standard Error of the Mean | 15.1 | 2-Sided | 90 | 86.142 | 101.570 | ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance. | Yes | Non-Inferiority or Equivalence | 90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided. The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation. |
| gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood) | gMean ratio | 88.19 | Standard Error of the Mean | 20.7 | 2-Sided | 90 | 78.60 | 98.95 | ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance. | Yes | Non-Inferiority or Equivalence | 90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided. The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation. |