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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018527-25 | EudraCT Number | EudraCT |
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This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1744 10 mcg | Experimental | solution for oral inhalation |
|
| Ketoconazole 400 mg | Experimental | tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 | Drug | 10 mcg solution for oral inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss) | AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | Day 8 of period 1 and day 14 of period 2 |
| Maximum Concentration at Steady State (Cmax,ss) | Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | Day 8 of period 1 and day 14 of period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. | Day 8 of period 1 and day 14 of period 2 |
| Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss) |
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Inclusion criteria Healthy male and female volunteers
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1222.47.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days. |
| 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 Curve From 0 to 1 Hour at Steady State (AUC0-1,ss) | AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picogram*hours/milliliter | Day 8 of period 1 and day 14 of period 2 |
|
First administration of trial medication until 6 days after last administration of trial medication
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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 | Olodaterol | Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C549647 | olodaterol |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| BI 1744 |
| Drug |
10 mcg solution for oral inhalation |
|
| Ketoconazole | Drug | 400 mg tablet |
|
| Ketoconazole | Drug | 400 mg tablet |
|
fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state. |
| Day 8 of period 1 and day 14 of period 2 |
| Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss) | Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | Day 8 of period 1 and day 14 of period 2 |
| Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss) | AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | Day 8 of period 1 and day 14 of period 2 |
| Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events. | First administration of trial medication until 6 days after last administration of trial medication |
| Assessment of Tolerability by the Investigator | The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. | End of period 1 and end of period 2 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Olodaterol Plus Ketoconazole | Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days. |
|
|
|
| Primary | Maximum Concentration at Steady State (Cmax,ss) | Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | PK analysis set with evaluable data for this endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picogram/milliliter | Day 8 of period 1 and day 14 of period 2 |
|
|
|
|
| Secondary | Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. | PK analysis set with evaluable data for this endpoint. | Posted | Median | Full Range | Hours | Day 8 of period 1 and day 14 of period 2 |
|
|
|
| Secondary | Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss) | fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state. | PK analysis set with evaluable data for this endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Day 8 of period 1 and day 14 of period 2 |
|
|
|
| Secondary | Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss) | Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | PK analysis set with evaluable data for this endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng | Day 8 of period 1 and day 14 of period 2 |
|
|
|
|
| Secondary | Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss) | AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV. | PK analysis set with evaluable data for this endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picogram*hours/milliliter | Day 8 of period 1 and day 14 of period 2 |
|
|
|
|
| Secondary | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events. | Treated set (TS) - Treated set includes all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Posted | Number | participants | First administration of trial medication until 6 days after last administration of trial medication |
|
|
|
| Secondary | Assessment of Tolerability by the Investigator | The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. | TS | Posted | Number | participants | End of period 1 and end of period 2 |
|
|
|
| 0 |
| 32 |
| 5 |
| 32 |
| EG001 | Olodaterol Plus Ketoconazole | Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days. | 0 | 32 | 9 | 32 |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide | ANOVA | Adjusted geometric mean ratio | 0.0001 | P-value for ratio outside 0.8-1.25 | Adjusted geometric mean ratio | 106.63 | Standard Deviation | 14.7 | 2-Sided | 90 | 100.211 | 113.463 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |
| Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide | ANOVA | Adjusted geometric mean ratio | 0.8991 | P-value for ratio outside 0.8-1.25 | Adjusted geometric mean ratio | 132.87 | Standard Deviation | 18.9 | 2-Sided | 90 | 122.732 | 143.843 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |
| Not satisfactory |
|
| Bad |
|
| Not assessable |
|