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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003281-13 | EudraCT Number |
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A study in healthy man to investigate the absolute bioavailability of 100mg BI 765080, once administered as subcutaneous (SC) injection and once administered as intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg BI 765080 SC injection (T) | Experimental |
| |
| 100 mg BI 765080 IV infusion (R) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 765080 | Drug | BI 765080 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 765080 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 765080 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)" |
| Maximum Measured Concentration of BI 765080 in Plasma (Cmax) | Maximum measured concentration of BI 765080 in plasma (Cmax) is reported. | Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)". |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)". |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phase 1 to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: http://mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility prior to participation in the trail. Subjects attend a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
The trial was randomized, open-label, and single-dose, with matched parallel groups (test treatment (T) group: subcutaneous (SC) injection of 100 milligram (mg) BI 765080; reference treatment (R) group: intravenous (IV) infusion of 100 mg BI 765080). Subjects in the T and R groups were matched based on age and body weight.
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg BI 765080 SC Injection (T) | Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC). |
| FG001 | 100 mg BI 765080 IV Infusion (R) | Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg BI 765080 SC Injection (T) | Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC). |
| BG001 | 100 mg BI 765080 IV Infusion (R) |
| Units | Counts |
|---|---|
| Participants |
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| 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 Concentration-time Curve of BI 765080 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 765080 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | The pharmacokinetic (PK) parameter analysis set (PKS): Including all subjects in the treated set (TS) who provided non-excluded data for at least one primary or secondary PK endpoint. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanogram/milliliter | Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)" |
|
From start of drug of administration until end of trial, up to 59 days.
Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
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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 | 100 mg BI 765080 SC Injection (T) | Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 24.1 | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2021 | Jun 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2022 | Jun 30, 2023 | SAP_001.pdf |
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| Occurrence of Drug-related Adverse Events | Percentage of participants with drug-related adverse events is reported. | From start of drug of administration until end of trial, up to 59 days. |
Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
|
Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).
| OG001 | 100 mg BI 765080 IV Infusion (R) | Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV). |
|
|
|
| Primary | Maximum Measured Concentration of BI 765080 in Plasma (Cmax) | Maximum measured concentration of BI 765080 in plasma (Cmax) is reported. | The pharmacokinetic (PK) parameter analysis set (PKS): Including all subjects in the treated set (TS) who provided non-excluded data for at least one primary or secondary PK endpoint. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Least Squares Mean | Standard Error | nanogram/milliliter | Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)". |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | The pharmacokinetic (PK) parameter analysis set (PKS): Including all subjects in the treated set (TS) who provided non-excluded data for at least one primary or secondary PK endpoint. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanogram/milliliter | Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)". |
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| Secondary | Occurrence of Drug-related Adverse Events | Percentage of participants with drug-related adverse events is reported. | Treated Set: Included all subjects who were randomised and treated with a dose of study drug. | Posted | Number | percentage of participants | From start of drug of administration until end of trial, up to 59 days. |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | 100 mg BI 765080 IV Infusion (R) | Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV). | 0 | 14 | 0 | 14 | 2 | 14 |
| Medical device site irritation | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Sense of oppression | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Electrocardiogram repolarisation abnormality | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 24.1 | 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.