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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002507-18 | EudraCT Number | EudraCT |
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To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Active Comparator | multiple doses of Rifampicin + single dose of Nintedanib |
|
| Reference | Experimental | single dose of Nintedanib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | single dose administration |
| |
| Rifampicin |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib |
| Maximum Measured Concentration (Cmax) | Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz) | AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib |
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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 |
|---|---|---|---|---|---|---|
| 1199.162.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29500603 | Derived | Luedtke D, Marzin K, Jungnik A, von Wangenheim U, Dallinger C. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):533-541. doi: 10.1007/s13318-018-0467-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nintedanib |
| |||||||||||||
| Washout Period of at Least 14 Days |
| |||||||||||||
| Nintedanib+ Rifampicin |
|
The treated set (TS) consists of all subjects who took at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days. |
| 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 the Curve From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | TS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib |
|
From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
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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 | Nintedanib | 150 mg of nintedanib was given as a single dose on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MEDDRA 15.1 | 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 |
|---|---|
| C530716 | nintedanib |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
single dose once daily for 7 days |
|
| Nintedanib | Drug | single dose administration |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1. |
|
|
|
| Primary | Maximum Measured Concentration (Cmax) | Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | TS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib |
|
|
|
|
| Secondary | Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz) | AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | TS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib |
|
|
|
|
| 0 |
| 26 |
| 5 |
| 26 |
| EG001 | Washout Period | washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered | 0 | 26 | 2 | 26 |
| EG002 | Rifampicin | 600 mg rifampicin was given every evening from Day -7 to Day -1 | 0 | 25 | 25 | 25 |
| EG003 | Nintedanib + Rifampicin | 600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1. | 0 | 25 | 4 | 25 |
| Headache | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 15.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |