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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001803-11 | EudraCT Number | EudraCT |
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To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment A | Active Comparator | 1 tablet afatinib single dose |
|
| treatment B | Experimental | 2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day |
|
| treatment C | Experimental | 2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| afatinib | Drug | standard therapeutic dose |
| |
| ritonavir + afatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve From 0 to tz (AUC0-tz) | AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post |
| Maximum Concentration (Cmax) | Cmax represents the maximum concentration of the analyte in plasma. | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post |
| Area Under Curve From 0 to ∞ Hours (AUC0-∞) | AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity. | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post |
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Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.151.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers. |
| 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 | Area Under Curve From 0 to tz (AUC0-tz) | AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. | This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post |
|
First administration of trial medication until 28 days after last administration of trial medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Afatinib | Subjects were treated with a single dose of Afatinib 40mg on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Drug |
simultaneous intake of ritonavir and afatinib on second treatment day |
|
| ritonavir + afatinib | Drug | on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose. |
| OG002 | Afatinib + Timed Rtv | Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose. |
|
|
|
| Primary | Maximum Concentration (Cmax) | Cmax represents the maximum concentration of the analyte in plasma. | This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post |
|
|
|
|
| Primary | Area Under Curve From 0 to ∞ Hours (AUC0-∞) | AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity. | This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post |
|
|
|
|
| 0 |
| 23 |
| 2 |
| 23 |
| EG001 | Afatinib + Concomittant Rtv | Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose. | 0 | 24 | 7 | 24 |
| EG002 | Afatinib + Timed Rtv | Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose. | 0 | 22 | 5 | 22 |
| Lipase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| ANOVA | Adjusted geometric mean ratio | 0.0012 | P-value for ratio outside interval 0.8-1.25 | Geometric mean ratio | 105.09 | Standard Deviation | 16.1 | 2-Sided | 90 | 96.425 | 114.530 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |
| ANOVA | Adjusted geometric mean ratio | 0.0000 | P-value for ratio outside interval 0.8-1.25 | Geometric mean ratio | 99.75 | Standard Deviation | 12.8 | 2-Sided | 90 | 93.328 | 106.610 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |
| ANOVA | Adjusted geometric mean ratio | 0.0005 | P-value for ratio outside interval 0.8-1.25 | Geometric mean ratio | 110.76 | Standard Deviation | 10.0 | 2-Sided | 90 | 104.936 | 116.913 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |
| ANOVA | Adjusted geometric mean ratio | 0.0003 | P-value for ratio outside interval 0.8-1.25 | Geometric mean ratio | 92.46 | Standard Deviation | 11.9 | 2-Sided | 90 | 86.928 | 98.341 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |