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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005585-17 | EudraCT Number |
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In order to assess the potential impact of steady state BI 425809 on CYP3A clinically, the effect of BI 425809 on the midazolam pharmacokinetics will be evaluated. Midazolam is a recommended substrate of CYP3A4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam alone (Reference (R)) / midazolam + iclepertin (BI 425809) (Test (T)) | Experimental | All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). All participants were also orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2) and 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). There was a washout phase of at least 24 hours between the administration of midazolam in Period 1 and the first iclepertin administration in Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug | midazolam |
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| 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) is presented. | Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809). |
| Maximum Measured Concentration of Midazolam in Plasma (Cmax) | Maximum measured concentration of midazolam in plasma (Cmax) is presented. | Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809). |
| 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-∞) is presented. | Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809). |
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Inclusion Criteria:
Exclusion Criteria:
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| 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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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 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 Phase I drug-drug interaction trial was performed as a non-randomised, open-label, two-period, crossover, one-sequence trial in order to investigate the effect of the offender drug iclepertin on the victim drug midazolam, based on an intra-subject comparison in healthy male subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam Alone (Reference (R)) / Midazolam + Iclepertin (BI 425809) (Test (T)) | All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). All participants were also orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2) and 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). There was a washout phase of at least 24 hours between the administration of midazolam in Period 1 and the first iclepertin administration in Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Wash-out period |
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| Period 2 |
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Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam Alone (Reference (R)) / Midazolam + Iclepertin (BI 425809) (Test (T)) | All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). All participants were also orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2) and 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). There was a washout phase of at least 24 hours between the administration of midazolam in Period 1 and the first iclepertin administration in Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. |
| 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 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) is presented. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set who provided at least one pharmacokinetics (PK) endpoint defined as primary or secondary and was not excluded due to protocol deviation relevant to evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomole/Liter (h*nmol/L) | Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809). |
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For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d.
Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all 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 | Midazolam Alone (Reference Treatment (R)) | All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 25.0 | 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 | Feb 16, 2022 | Feb 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2022 | Feb 27, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D012996 | Solutions |
| C000634404 | BI 425809 |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| iclepertin (BI 425809) | Drug | BI 425809 |
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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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All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. |
| OG001 | Iclepertin (BI 425809) + Midazolam (Test Treatment (T)) | All participants received 10 mg iclepertin orally once daily over 21 days (from Day -20 until Day 1 of Period 2). All participants were then orally administered 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. |
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| Primary | Maximum Measured Concentration of Midazolam in Plasma (Cmax) | Maximum measured concentration of midazolam in plasma (Cmax) is presented. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set who provided at least one pharmacokinetics (PK) endpoint defined as primary or secondary and was not excluded due to protocol deviation relevant to evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter (nmol/L) | Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809). |
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| 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-∞) is presented. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set who provided at least one pharmacokinetics (PK) endpoint defined as primary or secondary and was not excluded due to protocol deviation relevant to evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomole/Liter (h*nmol/L) | Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809). |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Iclepertin (BI 425809) Alone | All participants were orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. | 0 | 14 | 0 | 14 | 5 | 14 |
| EG002 | Iclepertin (BI 425809) + Midazolam | All participants were orally administered 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water. | 0 | 12 | 0 | 12 | 1 | 12 |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 25.0 | 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.
| D006571 | Heterocyclic Compounds |
| D004364 | Pharmaceutical Preparations |