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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003103-19 | EudraCT Number |
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To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with [C-14]BI 730357 BS administered as intravenous microtracer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Experimental | Test treatment T followed by Reference treatment R |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 730357 | Drug | Oral dose |
| |
| BI 730357 mixed with [C-14] BI 730357 BS |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized). | Area under the concentration-time curve of the analyte over the time interval from 0 to infinity (AUC0-∞). For both arms results are presented in millimole (mmol) * hours (h) / Litre (L) / kilogram (kg). This was achieved by transforming the reference arm to the treatment arm and normalizing the results according to the respective dose. | Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36919398 | Derived | Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1. |
| 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:
1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/
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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 trial was performed as a non-randomised, open-label, single arm, single period trial design in healthy male subjects in order to investigate the absolute oral bioavailability compared to the intravenous administered reference treatment of BI 730357.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | 1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T) followed by 100 microgram (μg) of BI 730357 base (BS) (C-14) (2 μg radiolabelled [C-14]BI 730357 BS mixed with 98 μg unlabeled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Treated set (TS) included all subjects who received at least 1 dose of trial medication. All 6 subjects were included in the TS. The safety analysis and the presentation of demographic and baseline characteristics were based on the TS.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | 1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T) followed by 100 microgram (μg) of BI 730357 base (BS) (C-14) (2 μg radiolabelled [C-14]BI 730357 BS mixed with 98 μg unlabeled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration. |
| 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 | Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized). | Area under the concentration-time curve of the analyte over the time interval from 0 to infinity (AUC0-∞). For both arms results are presented in millimole (mmol) * hours (h) / Litre (L) / kilogram (kg). This was achieved by transforming the reference arm to the treatment arm and normalizing the results according to the respective dose. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Standard Error | mmol*h/L/kg | Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion. |
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From the first administration of trial drug to the end of residual effect period up to 7 days.
Adverse events are reported based on treated set (TS). This subject set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
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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 | All Subjects | 1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T) followed by 100 microgram (μg) of BI 730357 base (BS) (C-14) (2 μg radiolabelled [C-14]BI 730357 BS mixed with 98 μg unlabeled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site bruise | General 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 | Nov 29, 2018 | Jul 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2019 | Aug 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
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| Drug |
Intravenous dose |
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| 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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| OG000 |
| BI 730357 50mg Tablet (T) |
1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T). |
| OG001 | BI 730357 BS (C-14) 100 µg Infusion (R) | 100 microgram (μg) of BI 730357 BS (C-14) (2 μg radiolabelled [C-14]BI 730357 base (BS) mixed with 98 μg unlabelled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration of test treatment (T). |
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| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| Erection increased | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.