Back to resultsRelative Bioavailability of of Olodaterol and Ketoconazole
Primary Purpose
Healthy, Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BI 1744
BI 1744
Ketoconazole
Ketoconazole
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion criteria Healthy male and female volunteers
Exclusion criteria
Sites / Locations
- 1222.47.1 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BI 1744 10 mcg
Ketoconazole 400 mg
Arm Description
solution for oral inhalation
tablet
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01153711
Brief Title
Relative Bioavailability of of Olodaterol and Ketoconazole
Official Title
Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Ketoconazole (Tablet) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BI 1744 10 mcg
Arm Type
Experimental
Arm Description
solution for oral inhalation
Arm Title
Ketoconazole 400 mg
Arm Type
Experimental
Arm Description
tablet
Intervention Type
Drug
Intervention Name(s)
BI 1744
Intervention Description
10 mcg solution for oral inhalation
Intervention Type
Drug
Intervention Name(s)
BI 1744
Intervention Description
10 mcg solution for oral inhalation
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Intervention Description
400 mg tablet
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Intervention Description
400 mg tablet
Primary Outcome Measure Information:
Title
Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)
Description
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.
Time Frame
Day 8 of period 1 and day 14 of period 2
Title
Maximum Concentration at Steady State (Cmax,ss)
Description
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.
Time Frame
Day 8 of period 1 and day 14 of period 2
Secondary Outcome Measure Information:
Title
Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
Description
tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.
Time Frame
Day 8 of period 1 and day 14 of period 2
Title
Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)
Description
fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.
Time Frame
Day 8 of period 1 and day 14 of period 2
Title
Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)
Description
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.
Time Frame
Day 8 of period 1 and day 14 of period 2
Title
Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)
Description
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.
Time Frame
Day 8 of period 1 and day 14 of period 2
Title
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Description
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.
Time Frame
First administration of trial medication until 6 days after last administration of trial medication
Title
Assessment of Tolerability by the Investigator
Description
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'.
Time Frame
End of period 1 and end of period 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Healthy male and female volunteers
Exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1222.47.1 Boehringer Ingelheim Investigational Site
City
Ingelheim
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1222/1222.47_U10-3390-01.pdf
Description
Related Info
Learn more about this trial
Relative Bioavailability of of Olodaterol and Ketoconazole
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