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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001534-97 | EudraCT Number |
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The primary objective of this trial is to investigate the relative bioavailability of BI 1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This assessment will be performed under fasted conditions. Furthermore, the effect of food on relative bioavailability of the tablet formulation of BI 1467335 will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1467335 (Treatment A) | Experimental | Tablet under fasted conditions |
|
| BI 1467335 (Treatment B) | Experimental | Oral solution under fasted conditions |
|
| BI 1467335 (Treatment C) | Experimental | Tablet under fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1467335 (Treatment A) | Drug |
| ||
| BI 1467335 (Treatment B) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz of BI 1467335 | This outcome measure presents AUC0-tz [area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to the last quantifiable data point]. | At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration. |
| Cmax of BI 1467335 | This outcome measure presents the maximum measured concentration of BI 1467335 in plasma (Cmax of BI 1467335). | At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration. |
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Inclusion Criteria:
Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP),Pulse Rate(PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Willingness to comply with contraception requirements. Subjects who are sexually active, must use, with their female partner, adequate contraception throughout the study and until one month after the last administration of trial medication. Adequate methods are:
Exclusion Criteria:
In addition, the following trial-specific exclusion criteria apply:
- Cataract in the medical history
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| 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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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.
The study was randomised, open-label, single-dose, three-way crossover trial. 18 subjects entered in the study. 18 subjects were treated in Treatment A: BI 1467335 10 mg tablets, fasted. 18 subjects were treated in Treatment B: BI 1467335 10 mg oral solution, fasted and 17 subjects were treated in Treatment C: BI 1467335 10 mg tablets, fed.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1467335: Tablets, Fasted/Solution, Fasted/Tablets, Fed | The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 1, followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10 hours [h] [Treatment B] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days. |
| FG001 | BI 1467335: Solution, Fasted/Tablets, Fed/Tablets, Fasted | The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast at least 10h [Treatment B] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state [Treatment A] orally with 240 mL of water after an overnight fast of at least 10h in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days. |
| FG002 | BI 1467335: Tablets, Fed/Tablets, Fasted/Solution, Fasted | The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 2, then followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h [Treatment B] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 [1 Day] |
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| Wash-out Period 1 [21 Days] |
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| Treatment Period 2 [1 Day] |
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| Wash-out Period 2 [21 Days] |
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| Treatment Period 3 [1 Day] |
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Treated set [TS]: All subjects who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1467335: Tablets, Fasted/Solution, Fasted/Tablets, Fed | The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 1, followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10 hours [h] [Treatment B] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days. |
| 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 | AUC0-tz of BI 1467335 | This outcome measure presents AUC0-tz [area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to the last quantifiable data point]. | PharmacoKinetic Set [PKS]: This subject set included all subjects in the Treated Set [All subjects who received at least one dose of study medication] who provided at least one primary PK parameter that was not excluded due to a relevant protocol violation [PV] or non-evaluable plasma concentrations. One subject did not receive the dose in period 2 [Tablets, fed]. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole*hour/Liter (nmol*h/L) | At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration. |
|
From the first day of study drug administration until 21 days after the first drug administration, up to 22 days.
Treated set [TS]: All subjects who received at least one dose of study medication.
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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 | BI 1467335: Tablets, Fasted | The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1800-243-0127 | 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 | Oct 12, 2016 | May 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2017 | May 11, 2021 | SAP_001.pdf |
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| Drug |
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| BI 1467335 (Treatment C) | Drug |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | BI 1467335: Solution, Fasted/Tablets, Fed/Tablets, Fasted | The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast at least 10h [Treatment B] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state [Treatment A] orally with 240 mL of water after an overnight fast of at least 10h in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days. |
| BG002 | BI 1467335: Tablets, Fed/Tablets, Fasted/Solution, Fasted | The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 2, then followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h [Treatment B] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state. The treatment duration was one day.
| OG001 | BI 1467335: Tablets, Fasted | The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day. |
| OG002 | BI 1467335: Solution, Fasted | The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day. |
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| Primary | Cmax of BI 1467335 | This outcome measure presents the maximum measured concentration of BI 1467335 in plasma (Cmax of BI 1467335). | PharmacoKinetic Set [PKS]: This subject set included all subjects in the Treated Set [All subjects who received at least one dose of study medication] who provided at least one primary PK parameter that was not excluded due to a relevant protocol violation [PV] or non-evaluable plasma concentrations. One subject did not receive the dose in period 2 [Tablets, Fed]. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/L) | At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration. |
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|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | BI 1467335: Solution, Fasted | The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day | 0 | 18 | 0 | 18 | 5 | 18 |
| EG002 | BI 1467335: Tablets, Fed | The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state. The treatment duration was one day. | 0 | 17 | 0 | 17 | 4 | 17 |
| Epididymitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Other |
| The statistical model used for the analysis of the endpoint was an ANOVA [Analysis of Variance] model on the logarithmic scale. This model included effects accounting for the following sources of variation: '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. | ANOVA | Ratio | 136.16 | Standard Deviation | 54.8 | 2-Sided | 90 | 99.885 | 185.61 | The estimated parameter was the adjusted geometric mean ratios [%] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type [SD] is the intra-individual geometric coefficient of variation [%]. | Other |