Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006676-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this trial is to investigate the relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral administration.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 425809 (reference treatment, R) then BI 425809 + bosentan (test treatment, T) | Experimental | Reference treatment (R): healthy male subjects administered orally once daily one film-coated tablet of 10 milligram (mg) of BI 425809 with 240 milliliter (mL) of water for 10 days (day 1 - day 10). Test treatment (T): healthy male subjects administered orally once daily one film-coated tablet of 10 mg of BI 425809 with 240 mL of water for 14 days (day 1 - day 14). In addition, subjects administered orally twice daily one film-coated tablet of 125 mg of bosentan with 240 mL of water for 14 days (day 1- day 14). Between the two periods, there was no wash-out period. Period 2 (T) immediately followed Period 1 (R). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 425809 | Drug | One daily film-coated tablet of 10 mg with 240 mL of water for 10 days (R) and for 14 days (T). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUCÏ„,ss) | Area under the concentration-time curve of BI 425809 in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss) is reported. The dosing interval Ï„ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1. | Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description). |
| Maximum Measured Concentration of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) | Maximum measured concentration of BI 425809 in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) is reported. The dosing interval Ï„ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1. | Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description). |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Concentration of BI 425809 in Plasma at Steady State Within a Uniform Dosing Interval Ï„ (Cmin,ss) | Minimum concentration of BI 425809 in plasma at steady state within a uniform dosing interval Ï„ (Cmin,ss) is reported. The dosing interval Ï„ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
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 was a non-randomised, open-label, two-period fixed sequence trial in healthy male subjects in order to compare the test treatment (T, BI 425809 given in combination with bosentan) to the reference treatment (R, BI 425809 given alone).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BI 425809 (Reference Treatment, R) Then BI 425809 + Bosentan (Test Treatment, T) | Reference treatment (R): healthy male subjects administered orally once daily one film-coated tablet of 10 milligram (mg) of BI 425809 with 240 milliliter (mL) of water for 10 days (day 1 - day 10). Test treatment (T): healthy male subjects administered orally once daily one film-coated tablet of 10 mg of BI 425809 with 240 mL of water for 14 days (day 1 - day 14). In addition, subjects administered orally twice daily one film-coated tablet of 125 mg of bosentan with 240 mL of water for 14 days (day 1- day 14). Between the two periods, there was no wash-out period. Period 2 (T) immediately followed Period 1 (R). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reference treatment (R) |
| |||||||||||||
| Transition period |
| |||||||||||||
| Test treatment (T) |
|
Treated set (TS): the TS included all subjects who were treated with at least 1 dose of trial drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 425809 (Reference Treatment, R) Then BI 425809 + Bosentan (Test Treatment, T) | Reference treatment (R): healthy male subjects administered orally once daily one film-coated tablet of 10 milligram (mg) of BI 425809 with 240 milliliter (mL) of water for 10 days (day 1 - day 10). Test treatment (T): healthy male subjects administered orally once daily one film-coated tablet of 10 mg of BI 425809 with 240 mL of water for 14 days (day 1 - day 14). In addition, subjects administered orally twice daily one film-coated tablet of 125 mg of bosentan with 240 mL of water for 14 days (day 1- day 14). Between the two periods, there was no wash-out period. Period 2 (T) immediately followed Period 1 (R). |
| 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 | Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUCÏ„,ss) | Area under the concentration-time curve of BI 425809 in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss) is reported. The dosing interval Ï„ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1. | Pharmacokinetic parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 pharmacokinetic (PK) endpoint that was defined as primary or secondary and 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 Least Squares Mean | Standard Error | hours * nanomole/liter (h*nmol/L) |
Period 1 (R): from first drug administration until first drug administration in period 2 (T) or, in case of treatment discontinuation, until 11 days after last treatment administration, up to 21 days. Period 2 (T): from first drug administration until 11 days after last treatment administration, or until trial termination, whatever occurs first, up to 25 days. All-cause mortality: from 1st drug intake until end of study, up to 38 days.
Treated set (TS): the TS included all subjects who were treated with at least 1 dose of trial drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1 (Reference Treatment (R)): BI 425809 | Reference treatment (R): healthy male subjects administered orally once daily one film-coated tablet of 10 mg of BI 425809 with 240 mL of water for 10 days (day 1 - day 10). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenopia | Eye disorders | 26.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2023 | Mar 2, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2023 | Mar 2, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000634404 | BI 425809 |
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Patients cross over from reference treatment (R) to test treatment (T) (two periods, fixed sequence).
Not provided
Not provided
Not provided
Not provided
|
| Bosentan | Drug | Two daily film-coated tablets of 125 mg with 240 mL of water for 14 days (T). |
|
|
| Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description). |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description). |
|
|
|
|
| Primary | Maximum Measured Concentration of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) | Maximum measured concentration of BI 425809 in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) is reported. The dosing interval Ï„ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1. | Pharmacokinetic parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 pharmacokinetic (PK) endpoint that was defined as primary or secondary and 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 Least Squares Mean | Standard Error | nanomole/liter (nmol/L) | Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description). |
|
|
|
|
| Secondary | Minimum Concentration of BI 425809 in Plasma at Steady State Within a Uniform Dosing Interval Ï„ (Cmin,ss) | Minimum concentration of BI 425809 in plasma at steady state within a uniform dosing interval Ï„ (Cmin,ss) is reported. The dosing interval Ï„ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1. | Pharmacokinetic parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 pharmacokinetic (PK) endpoint that was defined as primary or secondary and 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 Least Squares Mean | Standard Error | nanomole/liter (nmol/L) | Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description). |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | Period 2 (Test Treatment (T)): Bosentan + BI 425809 | Test treatment (T): healthy male subjects administered orally once daily one film-coated tablet of 10 mg of BI 425809 with 240 mL of water for 14 days (day 1 - day 14). In addition, subjects administered orally twice daily one film-coated tablet of 125 mg of bosentan with 240 mL of water for 14 days (day 1- day 14). | 0 | 13 | 0 | 13 | 7 | 13 |
| Dry eye | Eye disorders | 26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | 26.0 | Systematic Assessment |
|
| Catheter site inflammation | General disorders | 26.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | 26.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 26.0 | Systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | 26.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 26.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |