Relative Bioavailability of Olodaterol and Fluconazole - Full Text View

Purpose

This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

Condition	Intervention	Phase
Healthy Pulmonary Disease, Chronic Obstructive	Drug: BI 1744 Drug: Fluconazole	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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. Fluconazole (Hard Capsule) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)

Resource links provided by NLM:

Drug Information available for: Fluconazole Olodaterol

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
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.
Maximum Concentration at Steady State (Cmax,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
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.
Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
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.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: First administration of trial medication until 6 days after last administration of trial medication ] [ Designated as safety issue: No ]
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.
Assessment of Tolerability by the Investigator [ Time Frame: End of period 1 and end of period 2 ] [ Designated as safety issue: No ]
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'.


Enrollment:	35
Study Start Date:	May 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Olodaterol	Drug: BI 1744 10 mcg solution for oral inhalation
Experimental: Olodaterol + Fluconazole	Drug: BI 1744 10 mcg solution for oral inhalation Drug: Fluconazole 400 mg capsule

Eligibility


Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy male and female volunteers

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153724

Locations


Germany
1222.48.1 Boehringer Ingelheim Investigational Site
Berlin, Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01153724 History of Changes
Other Study ID Numbers:	1222.48, 2010-018528-18
Study First Received:	June 29, 2010
Results First Received:	March 28, 2014
Last Updated:	May 29, 2014
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:


Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Fluconazole 14-alpha Demethylase Inhibitors	Anti-Infective Agents Antifungal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015