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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018528-18 | EudraCT Number | EudraCT |
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This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olodaterol | Experimental |
| |
| Olodaterol + Fluconazole | Experimental |
|
| 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 6 Hours at Steady State (AUC0-6,ss) | AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours 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 (a metabolite of olodaterol) 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
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1222.48.1 Boehringer Ingelheim Investigational Site | Berlin | 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. 35 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 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| ||||||||||||||||||
| Treatment Period 2 |
|
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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. 35 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 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day). |
| 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 6 Hours at Steady State (AUC0-6,ss) | AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours 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
Adverse events presented for treated set which includes all patients who had taken at least 1 dose 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 |
|---|---|---|---|---|---|
| Constipation | 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 |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole |
| Drug |
400 mg capsule |
|
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 excreted in urine from 0 to time t=24 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 12 Hours at Steady State (AUC0-12,ss) | AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint 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 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 Fluconazole | Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule 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 (a metabolite of olodaterol) 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 | 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 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of olodaterol | 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 excreted in urine from 0 to time t=24 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 | 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 12 Hours at Steady State (AUC0-12,ss) | AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint 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 | 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 Adverse Events. | Treated set (TS) - Treated set includes all patients who had taken at least 1 dose of trial medication. | 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 |
| 35 |
| 2 |
| 35 |
| EG001 | Olodaterol Plus Fluconazole | Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days. | 0 | 34 | 18 | 34 |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Relative bioavailability
| Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide | ANOVA | Adjusted geometric mean ratio | 0.0711 | P-value for ratio outside interval 0.8-1.25 | Adjusted geometric mean | 85.98 | Standard Deviation | 19.4 | 2-Sided | 90 | 79.277 | 93.253 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |
Relative bioavailability
| Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide | ANOVA | Adjusted geometric mean ratio | 0.8574 | P-value for ratio outside interval 0.8-1.25 | Adjusted geometric mean ratio | 74.48 | Standard Deviation | 1.068 | 2-Sided | 90 | 66.619 | 83.266 | The standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | Relative bioavailability |
| Not satisfactory |
|
| Bad |
|
| Not assessable |
|