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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003224-24 | EudraCT Number |
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Terminated (Business Reasons)
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The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects.
The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection. |
|
| BI 473494 35 μg | Experimental | Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection. |
|
| BI 473494 75 μg | Experimental | Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 473494 | Drug | Solution for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs | Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. | From drug administration until End of trial (EOT), up to 40 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 473494 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz) | AUC0-tz, area under the concentration-time curve of BI 473494 over the time interval from 0 to the last quantifiable time point is presented. | Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
All participants were screened for eligibility to participate in the trial by the trial site. The site ensured that the participants met all strictly implemented inclusion/exclusion criteria. Participants were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
It was planned to include healthy participants in this single-rising dose trial with a single-blind, partially randomised, placebo controlled and parallel group design. They were recruited from the volunteer's pool of the study site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching BI 473494 | Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection. |
| FG001 | BI 473494 35 μg | Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection. |
| FG002 | BI 473494 75 μg | Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS) : The TS included all subjects who were dispensed study medication and were documented to have taken at least one dose of BI 473494.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching BI 473494 | Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection. |
| BG001 | BI 473494 35 μg | Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection. |
| 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 Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs | Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. | Treated set (TS) : The TS included all subjects who were dispensed study medication and were documented to have taken at least one dose of BI 473494. | Posted | Number | Percentage of participants (%) | From drug administration until End of trial (EOT), up to 40 days. |
|
From drug administration until End of trial (EOT), up to 40 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 Matching BI 473494 | Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute polyneuropathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
The study was terminated due to business reasons after the second of 11 planned dose groups. Therefore, only two dose groups were evaluated.
| 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 2, 2017 | Jun 28, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2019 | Mar 17, 2022 | SAP_001.pdf |
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| Placebo |
| Drug |
Solution for injection |
|
| Maximum Measured Concentration of BI 473494 (Cmax) | Cmax, maximum measured concentration of BI 473494 is presented. | Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1 |
| BG002 | BI 473494 75 μg | Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | BI 473494 35 μg | Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection. |
| OG002 | BI 473494 75 μg | Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection. |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 473494 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz) | AUC0-tz, area under the concentration-time curve of BI 473494 over the time interval from 0 to the last quantifiable time point is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects from the TS who received study medication and provided at least one secondary PK parameter that was not excluded due to important protocol deviations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole*Hours/Litre (nmol*h/L) | Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1 |
|
|
|
| Secondary | Maximum Measured Concentration of BI 473494 (Cmax) | Cmax, maximum measured concentration of BI 473494 is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects from the TS who received study medication and provided at least one secondary PK parameter that was not excluded due to important protocol deviations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole/Litre (nmol/L) | Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | BI 473494 35 μg | Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | BI 473494 75 μg | Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection. | 0 | 6 | 1 | 6 | 1 | 6 |
| Head discomfort | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA 22.0 | 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.