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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003560-31 | EudraCT Number | EudraCT |
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To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 416970 single rising dose part | Experimental | single rising dose given as tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 416970 | Drug | single rising doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug-related adverse events | AEs were recorded throughout the trial |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Cmax (maximum measured concentration of the analyte in plasma) | 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1345.1.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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The study was conducted in eight groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| FG001 | BI 416970 10mg | The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| FG002 | BI 416970 25mg | The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| FG003 | BI 416970 50mg | The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| FG004 | BI 416970 100mg | The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| FG005 | BI 416970 200mg | The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| FG006 | BI 416970 400mg | The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| FG007 | BI 416970 600mg | The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken ≥1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| BG001 | BI 416970 10mg |
| 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 | Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug-related adverse events | The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz. | Posted | Number | percentage of participants | AEs were recorded throughout the trial |
|
From the first intake of trial medication until the end of trial examination, up to 14 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 | Placebo | The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal infection | Infections and infestations | 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| BI 416970 |
| Drug |
single rising doses |
|
| AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) |
AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |
| 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration |
The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
| BG002 | BI 416970 25mg | The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| BG003 | BI 416970 50mg | The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| BG004 | BI 416970 100mg | The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| BG005 | BI 416970 200mg | The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| BG006 | BI 416970 400mg | The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| BG007 | BI 416970 600mg | The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | BI 416970 25mg | The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| OG003 | BI 416970 50mg | The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| OG004 | BI 416970 100mg | The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| OG005 | BI 416970 200mg | The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| OG006 | BI 416970 400mg | The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
| OG007 | BI 416970 600mg | The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. |
|
|
| Secondary | Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Cmax (maximum measured concentration of the analyte in plasma) | The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration |
|
|
|
|
| Secondary | AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration |
|
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | BI 416970 10 mg | The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. | 0 | 6 | 1 | 6 |
| EG002 | BI 416970 25 mg | The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. | 0 | 10 | 3 | 10 |
| EG003 | BI 416970 50 mg | The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. | 0 | 6 | 1 | 6 |
| EG004 | BI 416970 100 mg | The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 |
| EG005 | BI 416970 200 mg | The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. | 0 | 6 | 2 | 6 |
| EG006 | BI 416970 400 mg | The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. | 0 | 5 | 2 | 5 |
| EG007 | BI 416970 600 mg | The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h. | 0 | 6 | 1 | 6 |
| EG008 | Total BI 416970 Treatment | All patients affected by AEs during administration of BI 416970 medication . | 0 | 45 | 10 | 45 |
| EG009 | Total Treatment | All patients affected by AEs during entire treatment period. | 0 | 60 | 11 | 60 |
| Nasopharyngitis | Infections and infestations | 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 17.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
|
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| A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1. | Slope | 0.9568 | Standard Error of the Mean | 0.1019 | 2-Sided | 90 | 0.7830 | 1.1307 | Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28. | No | Superiority or Other |
| A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1. | Slope | 0.9603 | Standard Error of the Mean | 0.0838 | 2-Sided | 90 | 0.8174 | 1.1032 | Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28. | No | Superiority or Other |