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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000268-23 | EudraCT Number |
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BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1: R - T1 - T2 - T3 | Experimental | Treatments: R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole |
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| Treatment sequence 2: T1 - T3 - R - T2 | Experimental |
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| Treatment sequence 3: T2 - R - T3 - T1 | Experimental |
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| Treatment sequence 4: T3 - T2 - T1 - R | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1810631 - trial formulation 1 (TF1) | Drug | BI 1810631 - trial formulation 1 (TF1) |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was reported. Unit of geometric coefficient of variation (gCV) is %. | Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration. |
| Maximum Measured Concentration of BI 1810631 in Plasma (Cmax) | The maximum measured concentration of BI 1810631 in plasma (Cmax) was reported. Unit of geometric coefficient of variation (gCV) is %. | Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) was reported. Unit of geometric coefficient of variation (gCV) is %. | Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 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 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 study was to investigate the relative bioavailability of 2 different BI 1810631 oral formulations (trial formulation 1 [TF1], Reference [R] and new formulation [NF], Test 1 [T1]) under fasting conditions; BI 1810631 NF under fasting (T1) and fed (T2) conditions; BI 1810631 NF given alone (T1) and together with the proton pump inhibitor rabeprazole (T3) under fasting conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: R - T1 - T2 - T3 | The treatment sequence R-T1-T2-T3 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
| Title | Milestones | Reasons Not Completed | |||||
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| Period 1 |
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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, 2022 | Aug 27, 2025 |
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4-way crossover
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| BI 1810631 - new formulation (NF) | Drug | BI 1810631 - new formulation (NF) |
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| Rabeprazole sodium | Drug | Rabeprazole sodium |
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| FG001 | Treatment Sequence 2: T1 - T3 - R - T2 | The treatment sequence T1 - T3 - R - T2 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
| FG002 | Treatment Sequence 3: T2 - R - T3 - T1 | The treatment sequence T2 - R - T3 - T1 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
| FG003 | Treatment Sequence 4: T3 - T2 - T1 - R | The treatment sequence T3 - T2 - T1 - R was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
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| NOT COMPLETED |
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| Washout Period 1 |
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| Period 2 |
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| Washout Period 2 |
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| Period 3 |
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| Washout Period 3 |
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| Period 4 |
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Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: R - T1 - T2 - T3 | The treatment sequence R-T1-T2-T3 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
| BG001 | Treatment Sequence 2: T1 - T3 - R - T2 | The treatment sequence T1 - T3 - R - T2 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
| BG002 | Treatment Sequence 3: T2 - R - T3 - T1 | The treatment sequence T2 - R - T3 - T1 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
| BG003 | Treatment Sequence 4: T3 - T2 - T1 - R | The treatment sequence T3 - T2 - T1 - R was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations. Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition. T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was reported. Unit of geometric coefficient of variation (gCV) is %. | Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanomole / Liter (h*nmol/L) | Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration. |
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| Primary | Maximum Measured Concentration of BI 1810631 in Plasma (Cmax) | The maximum measured concentration of BI 1810631 in plasma (Cmax) was reported. Unit of geometric coefficient of variation (gCV) is %. | Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole / Liter (nmol/L) | Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration. |
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| Secondary | Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) was reported. Unit of geometric coefficient of variation (gCV) is %. | Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanomole / Liter (h * nmol/L) | Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration. |
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For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of 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 | TF1 Fasted (R) | Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG001 | NF Fasted (T1) | Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. | 0 | 12 | 0 | 12 | 1 | 12 |
| EG002 | NF Fed (T2) | Test 2 (T2): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fed condition. | 0 | 9 | 0 | 9 | 4 | 9 |
| EG003 | Rabeprazole | 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG004 | NF Fasted + Rabeprazole (T3) | Test 3 (T3): 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. | 0 | 11 | 0 | 11 | 4 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 18002430127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2022 | Aug 27, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Not attend visit |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Adjusted geometric means ratio (T2/T1) | 74.2 | 2-Sided | 90 | 67.6 | 81.6 | Unit of adjusted geometric means ratio (T2/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual geometric coefficient of variation (gCV) = 9.8% | Other | The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. |
| Adjusted geometric means ratio (T3/T1) | 97.1 | 2-Sided | 90 | 85.8 | 110.0 | Unit of adjusted geometric means ratio (T3/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual geometric coefficient of variation (gCV) = 13.8% | Other | The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. |
| OG003 | NF Fasted + Rabeprazole (T3) | Test 3 (T3): 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. |
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| NF Fed (T2) |
Test 2 (T2): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fed condition. |
| OG003 | NF Fasted + Rabeprazole (T3) | Test 3 (T3): 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition. |
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