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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004899-62 | EudraCT Number |
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The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality and pharmacodynamics (PD) of BI 1323495 after single dosing and the assessment of the PK/PD relationship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 1 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
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| Dose Group 2 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 2 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
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| Dose Group 3 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 3 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
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| Dose Group 4 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 4 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
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| Dose Group 5 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 5 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1323495 | Drug | Low strength tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events | Percentage of participants with drug-related adverse events. | From drug administration until end of trial, up to 15 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) after single oral administration of BI 1323495. | 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
In addition, the following trial-specific exclusion criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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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:
Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:
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All participants were screened for eligibility to participate in the trial. Participants attended specialist site which would then ensure that all 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.
This single-rising dose trial was designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching BI 1323495 | Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablets with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). |
| FG001 | BI 1323495 Dose Group 1 | Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG002 | BI 1323495 Dose Group 2 | Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG003 | BI 1323495 Dose Group 3 | Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG004 | BI 1323495 Dose Group 4 | Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG005 | BI 1323495 Dose Group 5 | Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG006 | BI 1323495 Dose Group 6 | Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG007 | BI 1323495 Dose Group 7 | Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG008 | BI 1323495 Dose Group 8 | Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching BI 1323495 | Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablets with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). |
| BG001 | BI 1323495 Dose Group 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 Participants With Drug-related Adverse Events | Percentage of participants with drug-related adverse events. | Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers. | 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): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
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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 1323495 | Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablet with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | 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 | Aug 28, 2018 | Jun 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2019 | Jun 29, 2023 | SAP_001.pdf |
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|
| Dose Group 6 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 6 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
|
| Dose Group 7 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 7 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
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| Dose Group 8 | Experimental | Participants were orally administered single dose of BI 1323495 dose group 8 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
|
| BI 1323495 | Drug | Middle strength tablet |
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| BI 1323495 | Drug | High strength tablet |
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| Placebo | Drug | Placebo to low strength tablet |
|
| Placebo | Drug | Placebo to middle strength tablet |
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| Placebo | Drug | Placebo to high strength tablet |
|
| Maximum Measured Concentration of BI 1323495 in Plasma (Cmax) | Maximum measured concentration of BI 1323495 in plasma (Cmax) after single oral administration of BI 1323495. | 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration. |
Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG002 | BI 1323495 Dose Group 2 | Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG003 | BI 1323495 Dose Group 3 | Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG004 | BI 1323495 Dose Group 4 | Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG005 | BI 1323495 Dose Group 5 | Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG006 | BI 1323495 Dose Group 6 | Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG007 | BI 1323495 Dose Group 7 | Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG008 | BI 1323495 Dose Group 8 | Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG009 | 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 |
|
Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG002 | BI 1323495 Dose Group 2 | Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG003 | BI 1323495 Dose Group 3 | Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG004 | BI 1323495 Dose Group 4 | Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG005 | BI 1323495 Dose Group 5 | Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG006 | BI 1323495 Dose Group 6 | Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG007 | BI 1323495 Dose Group 7 | Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG008 | BI 1323495 Dose Group 8 | Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) after single oral administration of BI 1323495. | Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects from the TS receiving BI 1323495 who provided at least 1 secondary PK parameter that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole (nmol)*hours (h) /Liter (L) | 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration. |
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| Secondary | Maximum Measured Concentration of BI 1323495 in Plasma (Cmax) | Maximum measured concentration of BI 1323495 in plasma (Cmax) after single oral administration of BI 1323495. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration. |
|
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| 0 |
| 15 |
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | BI 1323495 Dose Group 1 | Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | BI 1323495 Dose Group 2 | Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | BI 1323495 Dose Group 3 | Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | BI 1323495 Dose Group 4 | Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | BI 1323495 Dose Group 5 | Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | BI 1323495 Dose Group 6 | Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | BI 1323495 Dose Group 7 | Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG008 | BI 1323495 Dose Group 8 | Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG009 | BI 1323495 Total | Participants were orally administered single dose of BI 1323495 dose groups 1, 2, 3, 4, 5, 6, 7 and 8 film-coated tablets with 240 mL of water after an overnight fast of at least 10 h. | 0 | 48 | 0 | 48 | 16 | 48 |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Unevaluable event | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Glutamate dehydrogenase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
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| The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints. | Slope | 0.9244 | Standard Error of the Mean | 0.1220 | 2-Sided | 95 | 0.6764 | 1.1724 | Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope. | Other |
| The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints. | Slope | 0.8586 | Standard Error of the Mean | 0.1307 | 2-Sided | 95 | 0.5929 | 1.1242 | Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope. | Other |