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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502424-43-00 | Registry Identifier | CTIS |
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The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202.
The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single rising dose (SRD): Placebo matching BI 3000202 | Placebo Comparator | SRD part: A single administration of 1 film-coated tablet identical to the active BI 3000202 treatment was orally given with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). |
|
| SRD: Dose 1 - BI 3000202 | Experimental | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
|
| SRD: Dose 2 - BI 3000202 | Experimental | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
|
| SRD: Dose 3 - BI 3000202 | Experimental | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
|
| SRD: Dose 4 - BI 3000202 | Experimental | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3000202 | Drug | BI 3000202 |
|
| Measure | Description | Time Frame |
|---|---|---|
| SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator | Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, 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 on Day 1 plus REP of 48 hours, up to 2 days. |
| FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24) | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'. | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
| FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax) | Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24) | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24) was analyzed descriptively. | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
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Inclusion criteria
Exclusion criteria
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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. 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: https://www.mystudywindow.com/msw/datatransparency
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All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.
This trial consisted of two parts, a single rising dose (SRD) part and food effect (FE) part in healthy men. The SRD part was a randomized, single-blind, and placebo-controlled trial, while the FE part was randomized, open-label, single dose, and two-way cross-over. The subjects in the SRD part were mutually exclusive with those in the FE part.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Rising Dose (SRD): Placebo Matching BI 3000202 | SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). |
| FG001 | SRD: Dose 1 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| FG002 | SRD: Dose 2 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| FG003 | SRD: Dose 3 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| FG004 | SRD: Dose 4 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| FG005 | SRD: Dose 5 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| FG006 | SRD: Dose 6 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| FG007 | SRD: Dose 7 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| FG008 | Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T) | FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments. |
| FG009 | FE: Low Dose III BI 3000202 Fed (T) / Fasted (R) | FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Rising Dose (SRD): Placebo Matching BI 3000202 | SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). |
| BG001 | SRD: Dose 1 - BI 3000202 |
| 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 | SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator | Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, 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 includes all participants who were treated with at least one dose of the trial drug. | Posted | Count of Participants | Participants | From drug administration on Day 1 plus REP of 48 hours, up to 2 days. |
|
Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial 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 | Single Rising Dose (SRD): Placebo Matching BI 3000202 | SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (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 |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | 26.1 | 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 | May 25, 2023 | May 12, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2023 | May 12, 2026 | SAP_001.pdf |
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The SRD part of the trial is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups.
In the FE part, subjects participate in a randomised, open-label, two-way crossover trial part with two treatment periods.
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SRD part: single blinded FE part: open-label
|
| SRD: Dose 5 - BI 3000202 | Experimental | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
|
| SRD: Dose 6 - BI 3000202 | Experimental | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
|
| SRD: Dose 7 - BI 3000202 | Experimental | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
|
| Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T) | Experimental | FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments. |
|
| FE: Low dose III BI 3000202 fed (T) / fasted (R) | Experimental | FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments. |
|
| Placebo matching BI 3000202 | Drug | Placebo matching BI 3000202 |
|
| SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax) | Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively. | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
| FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to infinity (AUC0-∞). The AUC0-∞ endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| BG002 | SRD: Dose 2 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| BG003 | SRD: Dose 3 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| BG004 | SRD: Dose 4 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| BG005 | SRD: Dose 5 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| BG006 | SRD: Dose 6 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| BG007 | SRD: Dose 7 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| BG008 | Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T) | FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments. |
| BG009 | FE: Low Dose III BI 3000202 Fed (T) / Fasted (R) | FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments. |
| BG010 | 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 |
|
| OG000 |
| Single Rising Dose (SRD): Placebo Matching BI 3000202 |
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). |
| OG001 | SRD: Dose 1 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| OG002 | SRD: Dose 2 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| OG003 | SRD: Dose 3 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| OG004 | SRD: Dose 4 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| OG005 | SRD: Dose 5 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| OG006 | SRD: Dose 6 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
| OG007 | SRD: Dose 7 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. |
|
|
| Primary | FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24) | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'. | Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanomoles times hour per Liter | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
|
|
|
|
| Primary | FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax) | Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. | Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanomoles per Liter | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
|
|
|
|
| Secondary | SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24) | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24) was analyzed descriptively. | Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles times hour per Liter | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
|
|
|
| Secondary | SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax) | Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively. | Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles times hour per Liter | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
|
|
|
| Secondary | FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to infinity (AUC0-∞). The AUC0-∞ endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. | Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanomoles times hour per Liter | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | SRD: Dose 1 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | SRD: Dose 2 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | SRD: Dose 3 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | SRD: Dose 4 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | SRD: Dose 5 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | SRD: Dose 6 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | SRD: Dose 7 - BI 3000202 | SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG008 | Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) | FE part: Participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (R). | 0 | 12 | 0 | 12 | 2 | 12 |
| EG009 | FE Part: Low Dose III BI 3000202 Fed (= Test T) | FE part: Participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (T). | 0 | 12 | 0 | 12 | 1 | 12 |
| Diarrhoea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Medical device site rash | General disorders | 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
No formal hypothesis testing was conducted.
No formal hypothesis testing was conducted.
No formal hypothesis testing was conducted.