Relative Bioavailability of of Olodaterol and Ketoconazole

Phase 1

Completed

• Conditions: Healthy; Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: BI 1744; Drug: Ketoconazole

• Registration Number: NCT01153711
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Primary Completion: 2010-08
• Status Verified: 2014-03
• Results First Submitted: 2014-03-28
• Results First Submitted QC: 2014-03-28
• Last Update Submitted: 2014-03-28
• Results First Posted: 2014-04-30
• Last Update Posted: 2014-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoconazole 400 mg	BI 1744	tablet
BI 1744 10 mcg	BI 1744	solution for oral inhalation
Ketoconazole 400 mg	Ketoconazole	tablet
BI 1744 10 mcg	Ketoconazole	solution for oral inhalation

Primary Outcome Measures

Name	Time	Method
Maximum Concentration at Steady State (Cmax,ss)	Day 8 of period 1 and day 14 of period 2	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.
Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)	Day 8 of period 1 and day 14 of period 2	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.

Secondary Outcome Measures

Name	Time	Method
Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)	Day 8 of period 1 and day 14 of period 2	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)	Day 8 of period 1 and day 14 of period 2	fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG	First administration of trial medication until 6 days after last administration of trial medication	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.
Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)	Day 8 of period 1 and day 14 of period 2	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.
Assessment of Tolerability by the Investigator	End of period 1 and end of period 2	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'.
Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)	Day 8 of period 1 and day 14 of period 2	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.

Trial Locations

Locations (1)

1222.47.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany