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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000468-36 | EudraCT Number |
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Investigate the effect of steady state exposures of memantine on the steady-state pharmacokinetics of BI 425809 and vice versa in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 425809 | Drug | Film coated tablet |
| |
| Memantine |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : BI 425809) | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3. | Detailed time frame is described in the measure description section. |
| Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : BI 425809) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3. | Detailed time frame can be found in the measure description. |
| Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : Memantine) | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss). Comparison of BI 425809 + Memantine versus BI 425809. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3. |
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Inclusion Criteria:
Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects, or female subjects who meet any of the following criteria from the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
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 to participate in trial. Subjects visited specialist site to ensure that they met all implemented inclusion criteria. Subjects meeting the exclusion criteria were excluded.
Non-randomised, single-arm, open-Label, three-period, one fixed sequence cross-over Study to investigate the effects of memantine in steady state on the pharmacokinetics of BI 425809 in steady state and vice versa in healthy male and female subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 425809/Memantine/BI 425809+Memantine | Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 mL of water after an overnight fast of at least 10 hours once daily. Dose was up-titrated starting with one tablet of 5 mg for days 1-7, for days 8 -14 one tablet of 10 mg, for days 15-21 one tablet of 15 mg, for days 22 - 28 one tablet of 20 mg, and from days 29 - 35 of period 2 one tablet of 20 mg for period 2. Treatment Period 3 (Test (T)): Oral administration of 25 mg BI 425809 in combination with oral administration one tablet of 20 mg memantine with 240 mL of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 3. Periods 1 and 2 with a washout period of at least 7 days. Period 3 followed directly after Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
| |||||||||||||
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 425809/Memantine/BI 425809+Memantine | Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 mL of water after an overnight fast of at least 10 hours once daily. Dose was up-titrated starting with one tablet of 5 mg for days 1-7, for days 8 -14 one tablet of 10 mg, for days 15-21 one tablet of 15 mg, for days 22 - 28 one tablet of 20 mg, and from days 29 - 35 of period 2 one tablet of 20 mg for period 2. Treatment Period 3 (Test (T)): Oral administration of 25 mg BI 425809 in combination with oral administration one tablet of 20 mg memantine with 240 mL of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 3. Periods 1 and 2 with a washout period of at least 7 days. Period 3 followed directly after Period 2. |
| 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 the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : BI 425809) | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3. | 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 protocol deviations relevant to the evaluation of PK or due to PK non-evaluability | Posted | Geometric Mean | Standard Error | nanomol * hours per liter | Detailed time frame is described in the measure description section. |
Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set 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 | BI 425809 | Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.1 | 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2019 | Oct 28, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 19, 2019 | Jan 26, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C000634404 | BI 425809 |
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Film coated tablet |
|
| Detailed time frame is described in the measure description section. |
| Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : Memantine) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI Memantine. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3. | Detailed time frame can be found in the measure description. |
| Started Days 8 - 14: Multiple Doses of 10 mg Memantine qd |
|
| Started Days 15 - 21: Multiple Doses of 15 mg Memantine qd |
|
| Started Days 22 - 35: Multiple Doses of 20 mg Memantine qd |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| 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 the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : BI 425809) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3. | 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 protocol deviations relevant to the evaluation of PK or due to PK non-evaluability | Posted | Geometric Mean | Standard Error | nanomol per liter | Detailed time frame can be found in the measure description. |
|
|
|
|
| Primary | Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : Memantine) | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss). Comparison of BI 425809 + Memantine versus BI 425809. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3. | 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 protocol deviations relevant to the evaluation of PK or due to PK non-evaluability | Posted | Geometric Mean | Standard Error | nanomol * hours per liter | Detailed time frame is described in the measure description section. |
|
|
|
|
| Primary | Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (BI 425809 + Memantine : Memantine) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI Memantine. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as Primary and was not excluded due to protocol deviations relevant to the evaluation of PK or due to PK non-evaluability | Posted | Geometric Mean | Standard Error | nanomol per liter | Detailed time frame can be found in the measure description. |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 10 |
| 16 |
| EG001 | Memantine | Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily. Memantine was up-titrated starting with one tablet of 5 mg for days 1-7 of period 2, for days 8 -14 of period 2 one tablet of 10 mg Memantine daily, for days 15-21 one tablet of 15 mg Memantine daily, for days 22 - 28 of period 2 one tablet of 20 mg daily, and from days 29 - 35 of period 2 one tablet of 20 mg daily. | 0 | 15 | 0 | 15 | 10 | 15 |
| EG002 | Memantine + BI 425809 | Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3. | 0 | 15 | 0 | 15 | 10 | 15 |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vessel puncture site reaction | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Change in sustained attention | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Emotional disorder | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Listless | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eosinophil percentage increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 22.1 | 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.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |