Relative Bioavailability of of Olodaterol and Ketoconazole

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153711
• Other study ID #: 1222.47
• Secondary ID: 2010-018527-25
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2010
• Last updated: March 28, 2014
• Start date: May 2010

Study information

• Verified date: March 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

Inclusion criteria Healthy male and female volunteers

Exclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Healthy
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BI 1744
10 mcg solution for oral inhalation
• BI 1744
10 mcg solution for oral inhalation
• Ketoconazole
400 mg tablet
• Ketoconazole
400 mg tablet

Locations

Country	Name	City	State
Germany	1222.47.1 Boehringer Ingelheim Investigational Site	Ingelheim

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 8 of period 1 and day 14 of period 2	No
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.	Day 8 of period 1 and day 14 of period 2	No
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.	Day 8 of period 1 and day 14 of period 2	No
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.	Day 8 of period 1 and day 14 of period 2	No
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.	Day 8 of period 1 and day 14 of period 2	No
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.	Day 8 of period 1 and day 14 of period 2	No
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.	First administration of trial medication until 6 days after last administration of trial medication	No
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'.	End of period 1 and end of period 2	No