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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001036-10 | EudraCT Number |
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The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1595043 in healthy male subjects following oral administration of single rising doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg BI 1595043 | Experimental | 1 mg BI 1595043 |
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| 3 mg BI 1595043 | Experimental | 3 mg BI 1595043 |
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| 6 mg BI 1595043 | Experimental | 6 mg BI 1595043 |
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| 12 mg BI 1595043 | Experimental | 12 mg BI 1595043 |
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| 25 mg BI 1595043 | Experimental | 25 mg BI 1595043 |
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| 50 mg BI 1595043 | Experimental | 50 mg BI 1595043 |
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| 90 mg BI 1595043 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1595043 | Drug | BI 1595043 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events (AEs) | Percentage of participants with drug-related adverse events (AEs) is reported. | From drug administration until end of trial, up to 15 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is reported. | Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043". |
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Inclusion Criteria:
Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Unprotected sexual intercourse with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion
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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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Only subjects that met all the inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring was adhered throughout the trial conduct.
A single-blind, partially randomised, placebo-controlled study to test how different doses of BI 1595043 are tolerated in healthy men.
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| ID | Title | Description |
|---|---|---|
| FG000 | Matching Placebo | Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. |
| FG001 | 1 mg BI 1595043 | Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| FG002 | 3 mg BI 1595043 | Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| FG003 | 6 mg BI 1595043 | Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| FG004 | 12 mg BI 1595043 | Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| FG005 | 25 mg BI 1595043 | Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| FG006 | 50 mg BI 1595043 | Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| FG007 | 90 mg BI 1595043 | Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| FG008 | 160 mg BI 1595043 | Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Matching Placebo | Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. |
| BG001 | 1 mg BI 1595043 | Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| 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 | Treated Set (TS). |
| 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) | Percentage of participants with drug-related adverse events (AEs) is reported. | Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. | Posted | Number | Percentage of participants | From drug administration until end of trial, up to 15 days. |
|
From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
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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 | Matching Placebo | Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | 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 | Jan 14, 2021 | Jun 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2021 | Jun 29, 2023 | SAP_001.pdf |
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90 mg BI 1595043 |
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| 160 mg BI 1595043 | Experimental | 160 mg BI 1595043 |
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| Matching Placebo | Placebo Comparator | Matching Placebo |
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| Placebo | Drug | Placebo |
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| Maximum Measured Concentration of BI 1595043 in Plasma (Cmax) | Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported. | Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043". |
| BG002 | 3 mg BI 1595043 | Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| BG003 | 6 mg BI 1595043 | Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| BG004 | 12 mg BI 1595043 | Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| BG005 | 25 mg BI 1595043 | Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| BG006 | 50 mg BI 1595043 | Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| BG007 | 90 mg BI 1595043 | Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| BG008 | 160 mg BI 1595043 | Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| BG009 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Treated Set (TS). | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Treated Set (TS). | Count of Participants | Participants |
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| Race (NIH/OMB) | Treated Set (TS). | Count of Participants | Participants |
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Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
| OG002 | 3 mg BI 1595043 | Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| OG003 | 6 mg BI 1595043 | Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| OG004 | 12 mg BI 1595043 | Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| OG005 | 25 mg BI 1595043 | Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| OG006 | 50 mg BI 1595043 | Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| OG007 | 90 mg BI 1595043 | Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
| OG008 | 160 mg BI 1595043 | Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. |
|
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| Secondary | Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is reported. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with non-missing values are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours * nanomole / Liter | Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043". |
|
|
|
| Secondary | Maximum Measured Concentration of BI 1595043 in Plasma (Cmax) | Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole / Liter | Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043". |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 6 |
| 16 |
| EG001 | 1 mg BI 1595043 | Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 3 mg BI 1595043 | Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | 6 mg BI 1595043 | Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | 12 mg BI 1595043 | Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | 25 mg BI 1595043 | Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | 50 mg BI 1595043 | Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG007 | 90 mg BI 1595043 | Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG008 | 160 mg BI 1595043 | Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 2 | 6 |
| Angular cheilitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.1 | 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.