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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001653-14 | EudraCT Number |
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Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 730357 25 mg fast | Experimental | Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
|
| Placebo fast | Placebo Comparator | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours. |
|
| Placebo fed | Placebo Comparator | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast. |
|
| BI 730357 50 mg fast | Experimental | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours. |
|
| BI 730357 50mg/Placebo | Experimental | Subject was orally administered mixed treatment of BI 730357 50 mg and placebo, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 730357 | Drug | BI 730357 film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events (AEs) | Number of subjects with drug-related Adverse Events (AEs) assessed by the investigator. | From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Analyte BI 730357 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCtau,1) | Area under the concentration-time curve of the analyte BI 730357 in plasma over a uniform dosing interval tau after administration of the first dose (AUCtau,1). In this study AUCtau,1 = AUC0-24 | -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h and 23.5h after first dosing on Day1. |
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Inclusion Criteria:
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTC North GmbH & Co. KG, Hamburg | Hamburg | 20251 | Germany |
| 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. 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:
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All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
Randomised, placebo-controlled, double-blind design investigating multiple rising doses
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Fast | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours. |
| FG001 | Placebo Fed | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast. |
| FG002 | BI 730357 25 mg Fast | Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| FG003 | BI 730357 50 mg Fast | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours. |
| FG004 | BI 730357 50mg/Placebo | Subject was orally administered mixed treatment of BI 730357 50 mg and placebo, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| FG005 | BI 730357 50 mg Fed | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast. |
| FG006 | BI 730357 100 mg Fast | Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| FG007 | BI 730357 200 mg Fast | Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours |
| FG008 | BI 730357 200 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
| FG009 | BI 730357 400 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Fast | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours. |
| BG001 | Placebo Fed | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast. |
| 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 | Number of Subjects With Drug-related Adverse Events (AEs) | Number of subjects with drug-related Adverse Events (AEs) assessed by the investigator. | Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm) | Posted | Number | Participants | From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups) |
|
From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
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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 | Placebo Fast | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 21.0 | Non-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 | Jan 12, 2018 | Aug 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2018 | Aug 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| BI 730357 50 mg fed | Experimental | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast. |
|
| BI 730357 100 mg fast | Experimental | Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
|
| BI 730357 200 mg fast | Experimental | Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours |
|
| BI 730357 200 mg fed | Experimental | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
|
| BI 730357 400 mg fed | Experimental | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
|
| Placebo | Drug | Placebo |
|
| Midazolam | Drug | Once per day (QD) on Days -1, 3, and 14. Dose groups BI 730357 200 mg fed and BI 730357 400 mg fed |
|
| Maximum Measured Concentration of the Analyte BI 730357 in Plasma After Administration of the First Dose (Cmax) | Maximum measured concentration of the analyte BI 730357 in plasma after administration of the first dose (Cmax) | -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h and 23.5h after first dosing on Day1. |
| Area Under the Concentration-time Curve of BI 730357 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After Last Dose Administration. | Area under the concentration-time curve of BI 730357 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after last dose administration is reported. τ for 25, 50, 100 , 200 and 400 mg dose groups is: 24 hours (h). Time Frame: For 25, 50, and 100 mg dose groups: -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h, 23.5h, 47.5 and 71.5 h after last dose on Day14. For 200 and 400 mg dose groups: -0.5h before last dose and 1.0h, 2.0h, 3.0h, 4.0h and 24.0h after last dose on Day28. | Day 14 and Day 28 (Please refer description for the time frame in detail) |
| Maximum Measured Concentration of the Analyte BI 730357 in Plasma at Steady State Over a Uniform Dosing Interval τ After the Last Dose (Cmax,ss) | Maximum measured concentration of BI 730357 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after last dose administration is reported. τ for 25, 50, 100 , 200 and 400 mg dose groups is: 24 hours (h). Time Frame: For 25, 50, and 100 mg dose groups:-0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h, 23.5h, 47.5 and 71.5 h after last dose on Day14. For 200 and 400 mg dose groups: -0.5h before last dose and 1.0h, 2.0h, 3.0h, 4.0h and 24.0h after last dose on Day28. | Day 14 and Day 28 (Please refer description for the time frame in detail) |
| Lost to Follow-up |
|
| Other than stated above |
|
| BG002 | BI 730357 25 mg Fast | Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| BG003 | BI 730357 50 mg Fast | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours. |
| BG004 | BI 730357 50mg/Placebo | Subject was orally administered mixed treatment of BI 730357 50 mg and placebo, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| BG005 | BI 730357 50 mg Fed | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast. |
| BG006 | BI 730357 100 mg Fast | Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| BG007 | BI 730357 200 mg Fast | Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours |
| BG008 | BI 730357 200 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
| BG009 | BI 730357 400 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
| 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 |
|
| OG001 |
| Placebo Fed |
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast. |
| OG002 | BI 730357 25 mg Fast | Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| OG003 | BI 730357 50 mg Fast | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours. |
| OG004 | BI 730357 50 mg Fed | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast. |
| OG005 | BI 730357 100 mg Fast | Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours |
| OG006 | BI 730357 200 mg Fast | Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours |
| OG007 | BI 730357 200 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
| OG008 | BI 730357 400 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. |
|
|
| Secondary | Area Under the Concentration-time Curve of the Analyte BI 730357 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCtau,1) | Area under the concentration-time curve of the analyte BI 730357 in plasma over a uniform dosing interval tau after administration of the first dose (AUCtau,1). In this study AUCtau,1 = AUC0-24 | Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole (nmol)·hour (h)/ liter(L) | -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h and 23.5h after first dosing on Day1. |
|
|
|
|
| Secondary | Maximum Measured Concentration of the Analyte BI 730357 in Plasma After Administration of the First Dose (Cmax) | Maximum measured concentration of the analyte BI 730357 in plasma after administration of the first dose (Cmax) | Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole (nmol)/liter(L) | -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h and 23.5h after first dosing on Day1. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 730357 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After Last Dose Administration. | Area under the concentration-time curve of BI 730357 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after last dose administration is reported. τ for 25, 50, 100 , 200 and 400 mg dose groups is: 24 hours (h). Time Frame: For 25, 50, and 100 mg dose groups: -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h, 23.5h, 47.5 and 71.5 h after last dose on Day14. For 200 and 400 mg dose groups: -0.5h before last dose and 1.0h, 2.0h, 3.0h, 4.0h and 24.0h after last dose on Day28. | Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole (nmol)·hour (h)/ liter(L) | Day 14 and Day 28 (Please refer description for the time frame in detail) |
|
|
|
|
| Secondary | Maximum Measured Concentration of the Analyte BI 730357 in Plasma at Steady State Over a Uniform Dosing Interval τ After the Last Dose (Cmax,ss) | Maximum measured concentration of BI 730357 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after last dose administration is reported. τ for 25, 50, 100 , 200 and 400 mg dose groups is: 24 hours (h). Time Frame: For 25, 50, and 100 mg dose groups:-0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h, 23.5h, 47.5 and 71.5 h after last dose on Day14. For 200 and 400 mg dose groups: -0.5h before last dose and 1.0h, 2.0h, 3.0h, 4.0h and 24.0h after last dose on Day28. | Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole (nmol)/ liter(L) | Day 14 and Day 28 (Please refer description for the time frame in detail) |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 8 |
| 12 |
| EG001 | Placebo Fed | Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG002 | BI 730357 25 mg Fast | Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours. | 0 | 9 | 0 | 9 | 7 | 9 |
| EG003 | BI 730357 50 mg Fast | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours. | 0 | 10 | 0 | 10 | 6 | 10 |
| EG004 | BI 730357 50 mg Fed | Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG005 | BI 730357 100 mg Fast | Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours. | 0 | 9 | 0 | 9 | 4 | 9 |
| EG006 | BI 730357 200 mg Fast | Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours. | 0 | 9 | 0 | 9 | 8 | 9 |
| EG007 | BI 730357 200 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. | 0 | 9 | 0 | 9 | 4 | 9 |
| EG008 | BI 730357 400 mg Fed | Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast. | 0 | 9 | 0 | 9 | 6 | 9 |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| D006571 | Heterocyclic Compounds |
| Dose proportionality for AUC0-24 of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24 | Slope | 0.5964 | Standard Error of the Mean | 0.0575 | 2-Sided | 95 | 0.4777 | 0.7151 | Other | Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. |
| Dose proportionality for Cmax of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). | Slope | 0.6223 | Standard Error of the Mean | 0.0715 | 2-Sided | 95 | 0.4747 | 0.7699 | Other | Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. |
| Dose proportionality for AUCτ,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). | Slope | 0.5811 | Standard Error of the Mean | 0.0864 | 2-Sided | 95 | 0.4013 | 0.7609 | Other | Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. |
| Dose proportionality for Cmax,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). | Slope | 0.5799 | Standard Error of the Mean | 0.0656 | 2-Sided | 95 | 0.4441 | 0.7156 | Other | Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. |