Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002249-16 | 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
The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1015550 + midazolam treatment arm | Experimental | test and reference treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | BI 1015550 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2. | Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2. |
| Maximum Measured Concentration of Midazolam in Plasma (Cmax) | Maximum measured concentration of midazolam in plasma (Cmax). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2. | Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2. |
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 |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | 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 treatment if any of the entry criteria were violated.
Open-label, two period fixed sequence design trial to investigate the induction effect of multiple oral doses of 18 milligram (mg) of BI 1015550 twice daily (bid) on the pharmacokinetics of a single oral dose of midazolam.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam (R) / BI 1015550 + Midazolam (T) | A single dose of 1 milliliter (mL) of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1. In period 2, one film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T). There was a washout period of at least 24 hours between the reference treatment (R) and the first BI 1015550 administration in the test treatment (T). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Reference treatment period) |
| |||||||||||||
| Period 2 (Test treatment period) |
|
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 | Midazolam (R) / BI 1015550 + Midazolam (T) | A single dose of 1 milliliter (mL) of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1. In period 2, one film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T). There was a washout period of at least 24 hours between the reference treatment (R) and the first BI 1015550 administration in the test treatment (T). |
| 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 Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2. | 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 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 one PK parameter value for one period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | Hours * nanomol per liter (h*nmol/L) | Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2. |
For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days.
Treated Set (TS): This set 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 | Midazolam | A single dose of 1 mL of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim, Call Centre | 18002430127 | 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 | Sep 23, 2022 | Oct 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2023 | Oct 30, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| midazolam | Drug | midazolam |
|
| Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
|
| Primary | Maximum Measured Concentration of Midazolam in Plasma (Cmax) | Maximum measured concentration of midazolam in plasma (Cmax). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2. | 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 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 one PK parameter value for one period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | Nanomol per Liter (nmol/L) | Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2. | 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 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 one PK parameter value for one period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | Hours * nanomol per liter (h*nmol/L) | Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2. |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | BI 1015550 | One film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 in period 2. | 0 | 15 | 0 | 15 | 9 | 15 |
| EG002 | BI 101550 + Midazolam | One film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T) in period 2. | 0 | 15 | 0 | 15 | 0 | 15 |
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
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.
| D006571 | Heterocyclic Compounds |
| Other |
| Other |