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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004262-19 | EudraCT Number |
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The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg BI 765080 | Experimental | BI 765080 |
|
| Placebo group | Placebo Comparator | Placebo group |
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| 10 mg BI 765080 | Experimental | BI 765080 |
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| 25 mg BI 765080 | Experimental | BI 765080 |
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| 50 mg BI 765080 | Experimental | BI 765080 |
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| 100 mg BI 765080 | Experimental | BI 765080 |
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| 200 mg BI 765080 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 765080 | Drug | BI 765080 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug-related adverse events is presented. | Up to 87 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 765080 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 765080 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. | Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080. |
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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, phases I 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: https://www.mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended 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.
This is a Phase I, single-blind, randomized, placebo-controlled, parallel-group design trial to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 mg BI 765080 Group | Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| FG001 | 10 mg BI 765080 Group | Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| FG002 | 25 mg BI 765080 Group | Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| FG003 | 50 mg BI 765080 Group | Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| FG004 | 100 mg BI 765080 Group | Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| FG005 | 200 mg BI 765080 Group | Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| FG006 | Placebo Group | Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 mg BI 765080 Group | Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| BG001 | 10 mg BI 765080 Group | Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| 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 | Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug-related adverse events is presented. | Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. | Posted | Number | Percentage of Participants | Up to 87 days |
|
From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
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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 | 1 mg BI 765080 Group | Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | 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 | May 10, 2021 | Jun 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2021 | Jun 29, 2023 | SAP_001.pdf |
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BI 765080 |
|
| Placebo | Drug | Placebo; 0.9% saline for injection |
|
| Maximum Measured Concentration of BI 765080 in Serum (Cmax) | Maximum measured concentration of BI 765080 in serum (Cmax) is presented. | Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080. |
| BG002 | 25 mg BI 765080 Group | Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| BG003 | 50 mg BI 765080 Group | Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| BG004 | 100 mg BI 765080 Group | Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| BG005 | 200 mg BI 765080 Group | Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| BG006 | Placebo Group | Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| BG007 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 25 mg BI 765080 Group | Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| OG003 | 50 mg BI 765080 Group | Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| OG004 | 100 mg BI 765080 Group | Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| OG005 | 200 mg BI 765080 Group | Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
| OG006 | Placebo Group | Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 765080 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 765080 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. | Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability (as specified below). Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms/milliLitres (h*ng/mL) | Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 765080 in Serum (Cmax) | Maximum measured concentration of BI 765080 in serum (Cmax) is presented. | Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability (as specified below). Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliLitres (ng/mL) | Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | 10 mg BI 765080 Group | Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 25 mg BI 765080 Group | Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | 50 mg BI 765080 Group | Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | 100 mg BI 765080 Group | Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | 200 mg BI 765080 Group | Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | Placebo Group | Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1. | 0 | 12 | 0 | 12 | 5 | 12 |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Herpes zoster reactivation | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Reactogenicity event | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
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.